Below, in chronological order, are four 8-Ks filed
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Posted On: 01/09/2019 2:59:27 PM
Below, in chronological order, are four 8-Ks filed with regard to the testing of the cannabinoid based topical cream for treating psoriasis. Note how in the last 8-K filed on April 4, 2017 the study was all of a sudden expanded and it was to start in 2018.
By the time of this last 8-K a lot of poop had already hit the fan, Friedland the swindler had already sold his shares, Ziv Turner was fired, and the rest were in damage control mode. Below is an email response thread of two email exchanges. One is with Friedland and the other is with Alon Sinai. The Dec. 29, 2016 8-k refers to “healthy volunteers”, but on the May 11, 2017 email to me Alon Sinai states: “pre-clinical = on human tissues but not on human beings”. So were the studies being conducted up to that point on cadavers?
I’m really not sure who was responsible for the language used in the 8-ks and press releases but there is no doubt that it created a lot of confusion. In hindsight you don’t have to be a genius to conclude who was behind them and why a few of the characters are no longer with the company and why one in particular is facing SEC charges for committing fraud. We all know that shortly after this fiasco the Company brought on board Dr. Hirsch and Yossi Dagan to right the severely tilting ship. There is no doubt that we are all disappointed with regards to the share price, communication, etc. But if not for these guys, who knows maybe the ship would have sunk a long time ago. As for Alon Sinai, I’m really not sure what he brings to the table except that he’s probably a nice guy. Keeping in mind of course that he’s not costing the Company much because, if I’m not mistaken, he’s only working one day a week for the company.
12/29/2016 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
02/01/2017 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
03/20/2017 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
04/4/2017 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
I may have already shared these emails with some of you. Most of you also know that my name is not Bruce, but for obvious reasons I’ve redacted my last name. The emails are mostly boring but they do illustrate the confusion regarding the study. I love Friedland’s reply pretending that he doesn’t know anything and to just reference the March 20 8-K. This guy is an SOB and I sure hope Karma visits him at some point.
Original Message
From: Frank XXXXXX
To: Jeffrey Friedland
Sent: Sunday, March 26, 2017 10:40 PM
Subject: Re: OWCP-- NCT02976779, OWC-PSO-01, A Phase I, Double Blind
Thank you Jeffrey for the quick reply.
The March 20th 8-K filed with the SEC was unnecessary and a waste of time. I suspect that someone advised management that it would be good to come out with it. For whatever reason there was a misunderstanding that the company had promised results on March 20, 2017. This was in conjunction with an audio news release but the audio was very clear in stating that the results might be available by March, 2017 not March 20, 2017.
I read the 8-K very carefully:
The subject line makes reference to "promising preliminary results". The first sentence of the PR states that they "announced the highly promising results of its topical cream efficacy tests". So where are the results? Why don't they just release them and let us decide. Better still, much better in fact, why don't they release the findings in a peer reviewed medical journal? I just hate these kind of misleading press releases that basically promise more double-blind efficacy tests for other skin disorders and conditions, but they don't tell us how good the psoriasis efficacy tests were..."promising" or "highly promising" just doesn't cut it.
The truth is that the release was just fluff, as many have already observed, and that everything is still subject to positive completion of our safety IRB approved study.
I hope you can appreciate why this is disappointing and frustrating.
Yes I have contacted Ziv Turner, but as I said before, each time the response is very defensive. He's the one that made the outrageous comment about CannaTech. I understand that you are an advisor to the company, but it is my understanding that you are also invested in the company through your company Intiva Inc. I would think that as an investor you must have done your initial due diligence and probably still continue to do so. What I need is reassurance that the company is a going concern, and for obvious reasons that reassurance is best if it comes from someone like you, someone that is also invested in the company. I have tried getting answers from a couple of forums but they consist of mainly bashers of the stock or those that claim they will be holding the stock forever!
I have a graveyard with dozens of stocks from the dot.com era, and I'll be damned if OWCP is destined to the same fate.
Cheers,
Frank XXXXXXXX
Original Message
From: Jeffrey Friedland
To: Frank XXXXXXX ; jeffrey@jeffreyfriedland.com
Sent: Sunday, March 26, 2017 10:19 PM
Subject: Re: OWCP-- NCT02976779, OWC-PSO-01, A Phase I, Double Blind
Frank: I am an advisor to the company, but am only privy to information that has been publicly released. I'm not a member of the Company's management team.
Have you tried contacting Ziv Turner?
You may want to to take a look at the Company's March 20th 8-K filed with the SEC as I believe it references the most current status of the psoriasis creme.
Jeffrey Friedland, CEO
Friedland Capital Ltd.
Email jeffrey@friedlandcapital.com
Website www.friedlandcapital.com
Canadian Mobile 1 647 800 1280
US Direct 1 646 450 8909
My personal website and blog www.jeffreyfriedland.com
My Amazon author page www.amazon.com/author/jeffreyfriedland
On Sun, Mar 26, 2017, 7:57 PM Frank XXXXXX <fXXXXXX@rogers.com> wrote:
Hello Mr. Friedland,
I was made aware of OWCP back in January and I have invested a considerable amount of money on the purchase of the company's shares both restricted and on the open market. I have on a number of occasions tried to get answers from the company and every time I get replies that are, at best, defensive.
On March 9, I came across the ClinicalTrials.gov site and it seems that the clinical trials that everybody has been waiting for still has not started!
https://clinicaltrials.gov/ct2/show/results/NCT02976779
After questioning management and after first being accused of trying to get inside information, I got the following reply:
Hi . First , thanks for the support
Second , Just to be accurate :
The company did not announce the start of the study on February .
We announced that we received IRB approval to conduct the study.
The link :
It is a federal link and might not be up to date
After we received the approval , together with the hospital we recruited all the patients which mean the study is not open for free volunteers and , I guess , this what the link means.
Fair enough on the above explanation, but I find it incredible that I cannot find a single online reference to the study that do not originate directly from OWCP. I have a couple of friends that are dermatologists and neither one of them is aware of any studies to determine the safety & tolerability of a topical cream containing medical grade cannabis. I would think that if one were to Google "Yehuda Baruch" and "OWC Pharmaceutical" one would get at least one reference to the study that is not either from the company or a stock promotion site. Are they that tight lipped that nobody knows they exist?
When I emailed the company with the question as to why they were not participating at CannaTech 2017 (I also ccd you) the reply that I got was ridiculous. They said that the conference was mainly focused on "recreational cannabis". This was in their backyard, the March 1st conference in Boca Raton was not!
With regards to the company and its principals I have yet to find one single bit of evidence originating from a third party or from an Israeli publication that ties them to OWCP and cannabis research. I just have one question. Are they in fact doing the research that they say they are doing, and if so can someone provide proof? You are their advisor and contact person in the US so I hope you can help. I'm located in Toronto.
I would appreciate it if you did not forward my email to management nor to Jeff Smurlick. He is the most defensive of them all. It seems that the only time they were co-operative is when they were raising funds. Anyway I would really appreciate it if you could put my mind at ease. Thank you!
Best regards and to your continued success,
Frank
From: Frank XXXXXX
To: Alon Sinai
Cc: Mordechai Bignitz ; Jeff Smurlick ; XXXXXXXXXXXXXXXXXXX
Sent: Thursday, May 11, 2017 4:55 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hello Alon,
Thank you for your prompt and thorough response..even if it does seem I've been spanked! But I'm a big boy nearing 70 so I can take it..
.
To your credit, your reply is a refreshing change from past replies that I have received from the company. You have gone beyond what was expected and for that I am very appreciative.
I have read all of the official company filings & communications issued over the past several months and many from last year as well, so I'm quite familiar with the projected timelines that the company has put forth. I am especially aware of the need to safeguard and protect the company's IP. I would expect nothing less!
This morning in fact someone asked why is the company so "secretive"? My reply was: "I don't have an issue with the company being secretive when it comes to protecting its IP. Totally understood why they need to be tight lipped and guarded in this regard". I went on to comment that, "as frustrating and disheartening the last few weeks have been with regards to the share price, I remain very optimistic that the company will continue to progress, learn, and lead us in the right direction, even if we have to endure some growing pains along the way. Keep the faith, be patient! "
You have made it very clear that the term "volunteer" is somewhat of a misnomer and that in actuality participants have to be very carefully selected. Admittedly that is something that I did not consider.
Thanks again for taking the time to respond.
Regards,
Frank
From: Alon Sinai
To: Frank XXXXXX
Cc: Mordechai Bignitz ; Jeff Smurlick ; XXXXXXXXXXXXXXXXXXXX
Sent: Thursday, May 11, 2017 2:39 PM
Subject: RE: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Dear Frank and Hello everyone
First , thank you for contacting us .
I will try and stay as short and to the point as possible.
General:
OWC pharmaceutical research is a biotech company and not a toy manufacturer in an automated China production line .
I am sure you realize that R&D and exploring new inventions is unknown road . It's a road we have to build .
Luckily for you as a shareholder and us as a company our pre-clinical phase for the cream's efficacy study led to findings that ( being very careful) are unique , with no previous records of any scientific findings , even remotely close to what we found ! Up to 70% reduction of biological markers directly related to psoriasis.
FYI , pre-clinical = on human tissues but not on human beings .
I am also aware of many "web-speculations" on timing and scientific course . None of them is supported by any of the official company's filings or communications!
Last , as a prolog to my answers to your inquiry let me add :
I am not sure if you are aware at what conducting a safety clinical study ( similar to FDA phase I) so let me give you some highlights :
1. The tested people have to be 100% healthy and none biased .
2. They have to be picked Randomly ( responding to Adds) and prove that they are not associated with the company or its competitors.
3. After the first screening they have to go through physical and mental check up ( for instance , once we checked some of the volunteers we happily advised 2 women that they are pregnant)
4. Than all volunteers are invited to the hospital to try and determine , for each of them , dates and timing for attending the hospital. During the study some are always asking to re-schedule , due to personal issues .
There are many other items and pieces that has to fall in place to finish building the puzzle . That is why with most studies the safety stage is framed to take a year
your inquiries below :
1. NIH reporting system is not a "FedEx" tracking system . Most biotech companies report only final results , some report midterm. All for purpose of protecting IP and disclose as less as possible to their competitors. So do we
2. You cannot chose to volunteer from the follow reasons :
* all volunteers were chosen already
* in order to volunteer at the beginning, you had to reside in Israel and able to arrive at the hospital, twice a week for 3 months
Last
Our main focus right now Is :
* complete including our pre-clinical findings into our IP so it will be stronger and un breakable. ( we announced)
* follow up to the vested interest we generated with international organizations ( commercial and scientific) after we announced the pre clinical findings
* continue the preparations to get our product to the market
So forgive me , in advance , if I don't answer fast enough
Thanks
Alon
Alon Sinai, COO
One World Cannabis Ltd. (OWC)
22, Shacham Street (Beit Dvir, 2nd floor), Petach Tikva, Israel
Mailing Address: PO Box 8324, Petach Tikva, 4918103, Israel
Tel: + 972 (0)3 7582659; + 972 (0)52 4029178
Email: alon.sinai@OWCpharma.com
www.OWCpharma.com
From: Frank XXXXXX[mailto:fXXXXXX@rogers.com]
Sent: Wednesday, May 10, 2017 8:25 PM
To: Alon Sinai <alon.sinai@owcpharma.com>
Cc: Alon Sinai <alon.sinai@owcpharma.com>; Mordechai Bignitz <mordechai.bignitz@owcpharma.com>; Jeff Smurlick <jsmurlick@gmail.com>; XXXXXXXXXXXXXXXXX>; XXXXXXXXXXXXX <XXXXXXXXXXXXXXXXXXXXX>
Subject: Fw: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hello Mr. Sinai,
Re: https://clinicaltrials.gov/ct2/show/results/NCT02976779
I first asked you about this on March 9. The confusion that it has created and continues to do so is real and not imagined. Even Jeffrey Friedland admitted at the time that he did not know of its status. The same question "why is this study not open yet for participant recruitment" is being asked today and it continues to raise suspicion and concern.
Considering that the company's image and credibility is taking a beating, how difficult is it to answer a very specific question with a thoughtful and concise answer. At least it will clear the confusion with regards to this particular issue?
Perhaps you could re-read the email conversation starting from my initial email to you on March 9. After all your contact information is right on the site:
Contact: Alon Sinai, MSc 972 524029178 alon.sinai@owcpharma.com
If somebody were to call you expressing interest in being a participant in this study, what would you tell them?
I do not need another reply from Amir asking me if I am seeking "insider" information. I am not!!! Give it some thought as I will share your answer with others that have expressed the same concern.
In anticipation of your response, I thank you.
Regards,
Frank XXXXXXX
P.s. in my final reply below on March 12, I was being kind in stating that the clarification made "sense on all accounts". It is obvious when someone is not capable of or in a position to answer answer a very direct and simple question.
Original Message
From: Frank XXXXXXX
To: OWCP
Cc: Alon Sinai ; Jeff Smurlick
Sent: Sunday, March 12, 2017 12:37 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Thank you for the clarification, it is very much appreciated. What you state makes sense on all accounts.
Regards,
Frank XXXXXXX
Original Message
From: OWCP
To: Frank XXXXXX
Cc: Alon Sinai ; Jeff Smurlick
Sent: Sunday, March 12, 2017 12:21 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hi . First , thanks for the support
Second , Just to be accurate :
The company did not announce the start of the study on February .
We announced that we received IRB approval to conduct the study.
The link :
It is a federal link and might not be up to date
After we received the approval , together with the hospital we recruited all the patients which mean the study is not open for free volunteers and , I guess , this what the link means .
ב-12 במרץ 2017, בשעה 6:32, Frank XXXXXX <fXXXXXX@rogers.com> כתב/ה:
S
Hello,
Not at all. I am not asking for insider information and I hope that we are clear about this.
Online I came across this study:
https://clinicaltrials.gov/ct2/show/results/NCT02976779
Am I correct to assume that this is a different study than the one currently being conducted? My question was and still is: Considering the study was to have begun in February and it was expected to be completed in July 2017, however on this site it states: "this study is not yet open for participant recruitment", so why has it not begun yet and what is it's current status?
Please clarify.
Thank you,
Frank
Original Message
From: OWCP
To: Frank XXXXXX
Cc: Alon Sinai ; Jeff Smurlick
Sent: Saturday, March 11, 2017 10:54 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hi
If I can read Your email properly than it seems to me you are asking for inside information , which of course , cannot be disclosed .
Please clarify
נשלח מה-iPhone שלי
ב-12 במרץ 2017, בשעה 4:15, Frank XXXXXX <fXXXXXX@rogers.com> כתב/ה:
Hello Amir,
I sent the email below to Alon Sinai a few days ago but I still have not received a reply. Perhaps the email did not reach him. I just wanted to know the status of this particular study and why it has still not begun.
https://clinicaltrials.gov/ct2/show/results/NCT02976779
Please reply asap. I'm also not able to find any reference online to the current clinical trials other than from OWCP's website. Just wondering where in Israel it is being conducted and at which facility.
The following site makes reference only to a March 2015 study but it was not with regards to the psoriasis cream. https://www.centerwatch.com/search/?q=%22ONE%20WORLD%22
Thank you,
Frank
Original Message
From: Frank XXXXXX
To: alon.sinai@owcpharma.com
Sent: Thursday, March 09, 2017 1:13 PM
Subject: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hello Mr. Sinai,
This study was to have begun last month. Could you please shed some light on its current status and why it has not begun yet?
Thank you in advance for your response.
Best regards,
Frank
By the time of this last 8-K a lot of poop had already hit the fan, Friedland the swindler had already sold his shares, Ziv Turner was fired, and the rest were in damage control mode. Below is an email response thread of two email exchanges. One is with Friedland and the other is with Alon Sinai. The Dec. 29, 2016 8-k refers to “healthy volunteers”, but on the May 11, 2017 email to me Alon Sinai states: “pre-clinical = on human tissues but not on human beings”. So were the studies being conducted up to that point on cadavers?
I’m really not sure who was responsible for the language used in the 8-ks and press releases but there is no doubt that it created a lot of confusion. In hindsight you don’t have to be a genius to conclude who was behind them and why a few of the characters are no longer with the company and why one in particular is facing SEC charges for committing fraud. We all know that shortly after this fiasco the Company brought on board Dr. Hirsch and Yossi Dagan to right the severely tilting ship. There is no doubt that we are all disappointed with regards to the share price, communication, etc. But if not for these guys, who knows maybe the ship would have sunk a long time ago. As for Alon Sinai, I’m really not sure what he brings to the table except that he’s probably a nice guy. Keeping in mind of course that he’s not costing the Company much because, if I’m not mistaken, he’s only working one day a week for the company.
12/29/2016 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
Quote:
On December 29, 2016, OWC Pharmaceutical Research Corp. (the “Registrant”), through its wholly-owned Israeli subsidiary, One World Cannabis Ltd. (‘OWC”), entered into a Research Agreement with Medical Research Infrastructure Development and Health Services Fund by Chaim Sheba Medical Center
Quote:
Pursuant to the Research Agreement, the Fund shall perform a Phase I, double blind, randomized, placebo-controlled, maximal dose study (the “Study”) to determine the safety, tolerability of topical cream containing MGC (“Medical Grade Cannabis” or the “Study Drug”) in healthy volunteers, employing the services of Dr. Aviv Barzilay, Director of the Department of Dermatology- Chaim Sheba Medical Center, Tel Hashomer, Israel, to lead the Study (the “Investigator”).
Quote:
2. PRE-CONDITION
It is a condition precedent to the validity of this Research Agreement that this Agreement shall come into effect only after approval is received from (i) the Helsinki Committee; and (ii) the Hospital’s Committee for Research Contracts with Commercial Companies. The performance of the Study shall commence only after both committees have approved the Study.
02/01/2017 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
Quote:
OWC Pharmaceutical Research Corp., OTCQB: OWCP (the “Registrant”), through its wholly-owned Israeli subsidiary, One World Cannabis Ltd. (“OWC Ltd”), has been conducting study on the efficacy its proprietary cannabinoid-based topical cream for the treatment of skin conditions generally and psoriasis specifically, which commenced in November, 2016 (the “Study”).
Quote:
On February 1, 2017, following the very encouraging results that have been achieved at the mid-point of the Study, the Registrant’s Board of Directors and the management and scientific personnel of OWC Ltd have determined to extend the size and scope of the Study for the purpose of, among other things, checking the biological markers that have been generated to date with respect to the treatment of psoriasis (proliferation/ inhibition and several interleukins). Despite extending its size and scope of the Study, the Registrant expects to compete the Study within the same projected time frame.
03/20/2017 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
Quote:
On March 20, 2017, OWC Pharmaceutical Research Corp. ("OWC"issued a press release announcing the promising preliminary results from the efficacy testing of its cannabinoid-based topical cream for treating psoriasis, reporting significant reduction of several inflammation markers specific to psoriasis. OWC announced that it anticipates that the topical cream will be market-ready during 2017 Q2 and, subject to regulatory approvals from applicable jurisdictions, the topical cream should be available for use by those who suffer from psoriasis in the near term.
04/4/2017 8-K
https://www.marketwatch.com/investing/Stock/O...amp;type=8
Quote:
OWC Pharmaceutical Research Corp. ("OWC"
Quote:
A wide and in-depth multi-layer clinical study on Psoriasis and psychological aspects is targeted to start next year, 2018, after collection of data from patients to carefully plan the targets of such a unique study that will show a combination of cannabinoids treatments for a specific disease.
I may have already shared these emails with some of you. Most of you also know that my name is not Bruce, but for obvious reasons I’ve redacted my last name. The emails are mostly boring but they do illustrate the confusion regarding the study. I love Friedland’s reply pretending that he doesn’t know anything and to just reference the March 20 8-K. This guy is an SOB and I sure hope Karma visits him at some point.
Original Message
From: Frank XXXXXX
To: Jeffrey Friedland
Sent: Sunday, March 26, 2017 10:40 PM
Subject: Re: OWCP-- NCT02976779, OWC-PSO-01, A Phase I, Double Blind
Thank you Jeffrey for the quick reply.
The March 20th 8-K filed with the SEC was unnecessary and a waste of time. I suspect that someone advised management that it would be good to come out with it. For whatever reason there was a misunderstanding that the company had promised results on March 20, 2017. This was in conjunction with an audio news release but the audio was very clear in stating that the results might be available by March, 2017 not March 20, 2017.
I read the 8-K very carefully:
The subject line makes reference to "promising preliminary results". The first sentence of the PR states that they "announced the highly promising results of its topical cream efficacy tests". So where are the results? Why don't they just release them and let us decide. Better still, much better in fact, why don't they release the findings in a peer reviewed medical journal? I just hate these kind of misleading press releases that basically promise more double-blind efficacy tests for other skin disorders and conditions, but they don't tell us how good the psoriasis efficacy tests were..."promising" or "highly promising" just doesn't cut it.
The truth is that the release was just fluff, as many have already observed, and that everything is still subject to positive completion of our safety IRB approved study.
I hope you can appreciate why this is disappointing and frustrating.
Yes I have contacted Ziv Turner, but as I said before, each time the response is very defensive. He's the one that made the outrageous comment about CannaTech. I understand that you are an advisor to the company, but it is my understanding that you are also invested in the company through your company Intiva Inc. I would think that as an investor you must have done your initial due diligence and probably still continue to do so. What I need is reassurance that the company is a going concern, and for obvious reasons that reassurance is best if it comes from someone like you, someone that is also invested in the company. I have tried getting answers from a couple of forums but they consist of mainly bashers of the stock or those that claim they will be holding the stock forever!
I have a graveyard with dozens of stocks from the dot.com era, and I'll be damned if OWCP is destined to the same fate.
Cheers,
Frank XXXXXXXX
Original Message
From: Jeffrey Friedland
To: Frank XXXXXXX ; jeffrey@jeffreyfriedland.com
Sent: Sunday, March 26, 2017 10:19 PM
Subject: Re: OWCP-- NCT02976779, OWC-PSO-01, A Phase I, Double Blind
Frank: I am an advisor to the company, but am only privy to information that has been publicly released. I'm not a member of the Company's management team.
Have you tried contacting Ziv Turner?
You may want to to take a look at the Company's March 20th 8-K filed with the SEC as I believe it references the most current status of the psoriasis creme.
Jeffrey Friedland, CEO
Friedland Capital Ltd.
Email jeffrey@friedlandcapital.com
Website www.friedlandcapital.com
Canadian Mobile 1 647 800 1280
US Direct 1 646 450 8909
My personal website and blog www.jeffreyfriedland.com
My Amazon author page www.amazon.com/author/jeffreyfriedland
On Sun, Mar 26, 2017, 7:57 PM Frank XXXXXX <fXXXXXX@rogers.com> wrote:
Hello Mr. Friedland,
I was made aware of OWCP back in January and I have invested a considerable amount of money on the purchase of the company's shares both restricted and on the open market. I have on a number of occasions tried to get answers from the company and every time I get replies that are, at best, defensive.
On March 9, I came across the ClinicalTrials.gov site and it seems that the clinical trials that everybody has been waiting for still has not started!
https://clinicaltrials.gov/ct2/show/results/NCT02976779
After questioning management and after first being accused of trying to get inside information, I got the following reply:
Hi . First , thanks for the support
Second , Just to be accurate :
The company did not announce the start of the study on February .
We announced that we received IRB approval to conduct the study.
The link :
It is a federal link and might not be up to date
After we received the approval , together with the hospital we recruited all the patients which mean the study is not open for free volunteers and , I guess , this what the link means.
Fair enough on the above explanation, but I find it incredible that I cannot find a single online reference to the study that do not originate directly from OWCP. I have a couple of friends that are dermatologists and neither one of them is aware of any studies to determine the safety & tolerability of a topical cream containing medical grade cannabis. I would think that if one were to Google "Yehuda Baruch" and "OWC Pharmaceutical" one would get at least one reference to the study that is not either from the company or a stock promotion site. Are they that tight lipped that nobody knows they exist?
When I emailed the company with the question as to why they were not participating at CannaTech 2017 (I also ccd you) the reply that I got was ridiculous. They said that the conference was mainly focused on "recreational cannabis". This was in their backyard, the March 1st conference in Boca Raton was not!
With regards to the company and its principals I have yet to find one single bit of evidence originating from a third party or from an Israeli publication that ties them to OWCP and cannabis research. I just have one question. Are they in fact doing the research that they say they are doing, and if so can someone provide proof? You are their advisor and contact person in the US so I hope you can help. I'm located in Toronto.
I would appreciate it if you did not forward my email to management nor to Jeff Smurlick. He is the most defensive of them all. It seems that the only time they were co-operative is when they were raising funds. Anyway I would really appreciate it if you could put my mind at ease. Thank you!
Best regards and to your continued success,
Frank
From: Frank XXXXXX
To: Alon Sinai
Cc: Mordechai Bignitz ; Jeff Smurlick ; XXXXXXXXXXXXXXXXXXX
Sent: Thursday, May 11, 2017 4:55 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hello Alon,
Thank you for your prompt and thorough response..even if it does seem I've been spanked! But I'm a big boy nearing 70 so I can take it..
. To your credit, your reply is a refreshing change from past replies that I have received from the company. You have gone beyond what was expected and for that I am very appreciative.
I have read all of the official company filings & communications issued over the past several months and many from last year as well, so I'm quite familiar with the projected timelines that the company has put forth. I am especially aware of the need to safeguard and protect the company's IP. I would expect nothing less!
This morning in fact someone asked why is the company so "secretive"? My reply was: "I don't have an issue with the company being secretive when it comes to protecting its IP. Totally understood why they need to be tight lipped and guarded in this regard". I went on to comment that, "as frustrating and disheartening the last few weeks have been with regards to the share price, I remain very optimistic that the company will continue to progress, learn, and lead us in the right direction, even if we have to endure some growing pains along the way. Keep the faith, be patient! "
You have made it very clear that the term "volunteer" is somewhat of a misnomer and that in actuality participants have to be very carefully selected. Admittedly that is something that I did not consider.
Thanks again for taking the time to respond.
Regards,
Frank
From: Alon Sinai
To: Frank XXXXXX
Cc: Mordechai Bignitz ; Jeff Smurlick ; XXXXXXXXXXXXXXXXXXXX
Sent: Thursday, May 11, 2017 2:39 PM
Subject: RE: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Dear Frank and Hello everyone
First , thank you for contacting us .
I will try and stay as short and to the point as possible.
General:
OWC pharmaceutical research is a biotech company and not a toy manufacturer in an automated China production line .
I am sure you realize that R&D and exploring new inventions is unknown road . It's a road we have to build .
Luckily for you as a shareholder and us as a company our pre-clinical phase for the cream's efficacy study led to findings that ( being very careful) are unique , with no previous records of any scientific findings , even remotely close to what we found ! Up to 70% reduction of biological markers directly related to psoriasis.
FYI , pre-clinical = on human tissues but not on human beings .
I am also aware of many "web-speculations" on timing and scientific course . None of them is supported by any of the official company's filings or communications!
Last , as a prolog to my answers to your inquiry let me add :
I am not sure if you are aware at what conducting a safety clinical study ( similar to FDA phase I) so let me give you some highlights :
1. The tested people have to be 100% healthy and none biased .
2. They have to be picked Randomly ( responding to Adds) and prove that they are not associated with the company or its competitors.
3. After the first screening they have to go through physical and mental check up ( for instance , once we checked some of the volunteers we happily advised 2 women that they are pregnant)
4. Than all volunteers are invited to the hospital to try and determine , for each of them , dates and timing for attending the hospital. During the study some are always asking to re-schedule , due to personal issues .
There are many other items and pieces that has to fall in place to finish building the puzzle . That is why with most studies the safety stage is framed to take a year
your inquiries below :
1. NIH reporting system is not a "FedEx" tracking system . Most biotech companies report only final results , some report midterm. All for purpose of protecting IP and disclose as less as possible to their competitors. So do we
2. You cannot chose to volunteer from the follow reasons :
* all volunteers were chosen already
* in order to volunteer at the beginning, you had to reside in Israel and able to arrive at the hospital, twice a week for 3 months
Last
Our main focus right now Is :
* complete including our pre-clinical findings into our IP so it will be stronger and un breakable. ( we announced)
* follow up to the vested interest we generated with international organizations ( commercial and scientific) after we announced the pre clinical findings
* continue the preparations to get our product to the market
So forgive me , in advance , if I don't answer fast enough
Thanks
Alon
Alon Sinai, COO
One World Cannabis Ltd. (OWC)
22, Shacham Street (Beit Dvir, 2nd floor), Petach Tikva, Israel
Mailing Address: PO Box 8324, Petach Tikva, 4918103, Israel
Tel: + 972 (0)3 7582659; + 972 (0)52 4029178
Email: alon.sinai@OWCpharma.com
www.OWCpharma.com
From: Frank XXXXXX[mailto:fXXXXXX@rogers.com]
Sent: Wednesday, May 10, 2017 8:25 PM
To: Alon Sinai <alon.sinai@owcpharma.com>
Cc: Alon Sinai <alon.sinai@owcpharma.com>; Mordechai Bignitz <mordechai.bignitz@owcpharma.com>; Jeff Smurlick <jsmurlick@gmail.com>; XXXXXXXXXXXXXXXXX>; XXXXXXXXXXXXX <XXXXXXXXXXXXXXXXXXXXX>
Subject: Fw: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hello Mr. Sinai,
Re: https://clinicaltrials.gov/ct2/show/results/NCT02976779
I first asked you about this on March 9. The confusion that it has created and continues to do so is real and not imagined. Even Jeffrey Friedland admitted at the time that he did not know of its status. The same question "why is this study not open yet for participant recruitment" is being asked today and it continues to raise suspicion and concern.
Considering that the company's image and credibility is taking a beating, how difficult is it to answer a very specific question with a thoughtful and concise answer. At least it will clear the confusion with regards to this particular issue?
Perhaps you could re-read the email conversation starting from my initial email to you on March 9. After all your contact information is right on the site:
Contact: Alon Sinai, MSc 972 524029178 alon.sinai@owcpharma.com
If somebody were to call you expressing interest in being a participant in this study, what would you tell them?
I do not need another reply from Amir asking me if I am seeking "insider" information. I am not!!! Give it some thought as I will share your answer with others that have expressed the same concern.
In anticipation of your response, I thank you.
Regards,
Frank XXXXXXX
P.s. in my final reply below on March 12, I was being kind in stating that the clarification made "sense on all accounts". It is obvious when someone is not capable of or in a position to answer answer a very direct and simple question.
Original Message
From: Frank XXXXXXX
To: OWCP
Cc: Alon Sinai ; Jeff Smurlick
Sent: Sunday, March 12, 2017 12:37 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Thank you for the clarification, it is very much appreciated. What you state makes sense on all accounts.
Regards,
Frank XXXXXXX
Original Message
From: OWCP
To: Frank XXXXXX
Cc: Alon Sinai ; Jeff Smurlick
Sent: Sunday, March 12, 2017 12:21 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hi . First , thanks for the support
Second , Just to be accurate :
The company did not announce the start of the study on February .
We announced that we received IRB approval to conduct the study.
The link :
It is a federal link and might not be up to date
After we received the approval , together with the hospital we recruited all the patients which mean the study is not open for free volunteers and , I guess , this what the link means .
ב-12 במרץ 2017, בשעה 6:32, Frank XXXXXX <fXXXXXX@rogers.com> כתב/ה:
S
Hello,
Not at all. I am not asking for insider information and I hope that we are clear about this.
Online I came across this study:
https://clinicaltrials.gov/ct2/show/results/NCT02976779
Am I correct to assume that this is a different study than the one currently being conducted? My question was and still is: Considering the study was to have begun in February and it was expected to be completed in July 2017, however on this site it states: "this study is not yet open for participant recruitment", so why has it not begun yet and what is it's current status?
Please clarify.
Thank you,
Frank
Original Message
From: OWCP
To: Frank XXXXXX
Cc: Alon Sinai ; Jeff Smurlick
Sent: Saturday, March 11, 2017 10:54 PM
Subject: Re: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hi
If I can read Your email properly than it seems to me you are asking for inside information , which of course , cannot be disclosed .
Please clarify
נשלח מה-iPhone שלי
ב-12 במרץ 2017, בשעה 4:15, Frank XXXXXX <fXXXXXX@rogers.com> כתב/ה:
Hello Amir,
I sent the email below to Alon Sinai a few days ago but I still have not received a reply. Perhaps the email did not reach him. I just wanted to know the status of this particular study and why it has still not begun.
https://clinicaltrials.gov/ct2/show/results/NCT02976779
Please reply asap. I'm also not able to find any reference online to the current clinical trials other than from OWCP's website. Just wondering where in Israel it is being conducted and at which facility.
The following site makes reference only to a March 2015 study but it was not with regards to the psoriasis cream. https://www.centerwatch.com/search/?q=%22ONE%20WORLD%22
Thank you,
Frank
Original Message
From: Frank XXXXXX
To: alon.sinai@owcpharma.com
Sent: Thursday, March 09, 2017 1:13 PM
Subject: NCT02976779, OWC-PSO-01, A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers
Hello Mr. Sinai,
This study was to have begun last month. Could you please shed some light on its current status and why it has not begun yet?
Thank you in advance for your response.
Best regards,
Frank
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