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

To: Thure Meyer who wrote (647)	3/12/1998 2:29:00 PM
From: Doug Bean	Respond to of 1837

Thure: Remember this is a "new" drug application and so it no longer matter if it is the "equivelant" of Premarin , only if it is effective in treating the problem it is supposed to. It shouldn't matter what compounds are active or not, only if they work. That said I agree with you that AHP will try anything they can to derail it and it appears that the FDA is willing to cooperate with AHP if they can without looking too bad. I wonder if there is any small way we can focus more attention on the FDA to make sure they are aware they are being watched? Congressmen etc. Womens groups would be the strongest voice. Many of the women congress persons may be subject to lobbying pressures too. CRDoug CRDoug

To: Thure Meyer who wrote (647)	3/14/1998 6:02:00 AM
From: vestor	Read Replies (1) \| Respond to of 1837

DRMD previously went in with an ANDA application. They were seeking bio-equivalency. However in a close vote they were denied due to the absence of an inert substance. DRMD maintained that the absence did not affect the efficacy. Now as an NDA I believe they will prevail despite the forces against them...Any idea as to how long it will take to know ?