Hi Gary, regarding the updating of the clinical tr
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Posted On: 09/15/2017 9:17:18 AM
Hi Gary, regarding the updating of the clinical trials database.
https://clinicaltrials.gov/ct2/show/results/NCT02976779
I first contacted management back in March with regards to the above site and why it still states that: "The study is not open yet for participant recruitment". After several unsatisfactory attempts at getting a reasonable answer I finally received an email from Alon Sinai on May 11. To summarize he essentially stated that:
1. All volunteers were already chosen.
2. Most biotech companies report only final results , some report midterm, and for obvious reasons they do the same.
3. Most studies at the safety stage are framed to take a year.
Back in May I shared the email by PM with a few people but was reluctant to post it publicly. My reluctance stems from the fact that there are too many people here that either don't want the company to succeed or they misinterpret everything they read and distort it to suit their purposes, whatever they may be.
As for me, I don't need a blow-by-blow description on how the study is going and what they are having for breakfast. I'm happy with the answer I got to that one question, and I'm prepared to wait for as long as it takes.
Thanks
Here is the May 11 email response from Alon Sinai.
Dear xxxxx 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
https://clinicaltrials.gov/ct2/show/results/NCT02976779
I first contacted management back in March with regards to the above site and why it still states that: "The study is not open yet for participant recruitment". After several unsatisfactory attempts at getting a reasonable answer I finally received an email from Alon Sinai on May 11. To summarize he essentially stated that:
1. All volunteers were already chosen.
2. Most biotech companies report only final results , some report midterm, and for obvious reasons they do the same.
3. Most studies at the safety stage are framed to take a year.
Back in May I shared the email by PM with a few people but was reluctant to post it publicly. My reluctance stems from the fact that there are too many people here that either don't want the company to succeed or they misinterpret everything they read and distort it to suit their purposes, whatever they may be.
As for me, I don't need a blow-by-blow description on how the study is going and what they are having for breakfast. I'm happy with the answer I got to that one question, and I'm prepared to wait for as long as it takes.
Thanks
Here is the May 11 email response from Alon Sinai.
Dear xxxxx 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
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