Posted by Michael Bell on December 27, 2004, at 20:15:40
In reply to Re: Ocinaplon is coming ... and I have a good feel, posted by jclint on December 27, 2004, at 19:48:20
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You're right, 28 days is very short for a phase III. But often times more than one Phase III trial is conducted. The FDA may have interest in fast-tracking this drug, however, if it truly offers a very effective and non-habit forming alternative to benzos.The time period between phase III trials and approval range, depending on lingering safety concerns, pressure from outside sources, etc. Could take months, possibly 1-2 years. I'd be interested to know why the phase III trial for ocinaplon is so short.
That seemed a very quick trial. It truly looks fantastic, but I am skeptical about how long before we see it. I hope I'm wrong.
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> Just to clarify, after phase III, the next stage is seeking approval from the drug regulatory bodies?
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> And to get things in perspective, how long did other recent drugs take to get to market once they reached this stage?
poster:Michael Bell
thread:434701
URL: http://www.dr-bob.org/babble/20041223/msgs/434756.html