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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product -- Ignore unavailable to you. Want to Upgrade?


To: tommysdad who wrote (906)2/13/1999 7:08:00 PM
From: Doug Bean  Read Replies (1) | Respond to of 1837
 
Okay, Now i am confused. I am under the impression that phase III studies have been done for the purposes that DRMD is submitting the NDA. Is this right or wrong. If not what was the last double blind study that we waited for? If it was not a phaseIII . Could the FDA then say something like " well we like the look of the NDA so far but would like to see further studies done" Would they be asking then for a phase III or something else? I know DRMD is trying to blow this by for a very narrow purpose and they have compeleted satisfactory studies wherein it worked well. My concern is , I understand that AHP is developing their own conjugated estrogen and further stalling by the FDA could possibly make all this a mute point if it goes on for another year or more. CRDoug