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Re: None

Wednesday, 03/20/2013 10:05:32 AM

Wednesday, March 20, 2013 10:05:32 AM

Post# of 8779
So - reading all the PR we bought in when it was PRTN, then the ticker was changed causing some confusion for a lot of people. Then reading the PR it was pretty clear that the company in August 2012 was preparing to begin the work for clinical trials back then. Now a poster got an email back in February from Withrow, claiming that the company was now in Pre-IRB..checking the IRB information out, it seems that this protocol only takes 3 weeks to 6 weeks. So if they knew that back in August 2012 and started the protocol, there should have been news back in October 2012. Nothing. So in actual fact it appears that nothing has been done since last summer because if they were proceeding toward trials, the IRB would have been completed early on. Now a month ago we are still pre-IRB? I'm confused. If they haven't even applied yet, and are still pre...then what was the point of getting everyone all pumped up based on the PR? Everyone has been more than patient but I feel that the PR hasn't lined up with what we are hearing.
When may I begin data collection for my study?
You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRB approval.

13. How long will it take for me to obtain approval to do my study?
That depends on the nature of your study and the characteristics of the people you intend to recruit. Research projects that involve only minimal risks are eligible for expedited review, for which you should allow at least 3 weeks for IRB review.

Research projects that involve greater than minimal risk to participants will need to go to the full board for review, which is scheduled for the first Friday of every month. For applications requiring full board review, you should allow at least 4-6 weeks for review and approval of your study.
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