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Re: Anxiety, Ocinaplon and clinical trials » Steve3211

Posted by pseudonym on March 16, 2005, at 18:46:34

In reply to Re: Anxiety, Ocinaplon and clinical trials, posted by Steve3211 on March 15, 2005, at 15:30:06

> So when possibly could we see a possible approval or release of phase III into pending approval.
> Best Steve

Well, I need to educate myself more on the FDA's procedures, because at one time the pacing item for ocinaplon regarding phase III was the two year carcinogenicity study. Perhaps others know better. If they have all the enrollees by July 2006, let's say, and the study takes 6 weeks, I'm not sure how long at that point, assuming safety is established, the collation, submission, and turnaround might be.


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