Re: The Clinicaltrail.gov site says July.
https://clinicaltrials.gov/ct2/show/NCT029767...amp;rank=1
This is incorrect. It created confusion for me and many others. Below is a series of back and forth emails with the company back in March. I gather that the one and only study that was meant to be done was the one done in Israel.
From: Me
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
From: Me To:OWCP Cc: Alon Sinai ; Jeff Smurlick
Sent: Saturday, March 11, 2017 9:44 PM
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
Original Message
From: OWCP To: Me 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 כתב/ה: From: Me To:OWCP Cc: Alon Sinai ; Jeff Smurlick Sent: Saturday, March 12, 2017 12:32 AM 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,
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
Original Message
From: OWCP To: Me 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, > כתב/ה:
S
From: Me 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
https://clinicaltrials.gov/ct2/show/NCT029767...amp;rank=1
This is incorrect. It created confusion for me and many others. Below is a series of back and forth emails with the company back in March. I gather that the one and only study that was meant to be done was the one done in Israel.
From: Me
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
From: Me To:OWCP Cc: Alon Sinai ; Jeff Smurlick
Sent: Saturday, March 11, 2017 9:44 PM
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
Original Message
From: OWCP To: Me 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 כתב/ה: From: Me To:OWCP Cc: Alon Sinai ; Jeff Smurlick Sent: Saturday, March 12, 2017 12:32 AM 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,
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
Original Message
From: OWCP To: Me 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, > כתב/ה:
S
From: Me 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
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