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

To: harkenman who wrote (904)	2/13/1999 12:22:00 PM
From: art slott	Respond to of 1837

Mucho thanks for the clarification. Any idea on how long the regulatory and testing process will take on MPA Cenestin? Art

To: harkenman who wrote (904)	2/13/1999 6:15:00 PM
From: tommysdad	Read Replies (1) \| Respond to of 1837

Umm, not quite. INDA = Investigational New Drug Application. That's the first submission, before a Phase I is started. FDA can come back and say "no, don't do this study", but technically they don't "approve" an INDA. 30 days after submission of an INDA, a company can commence clinical trials (typically Phase I, but sometimes PI/IIa). "Once IND results are in": I don't know what you mean by this. NDA = New Drug Application. It is NOT an application to do Phase III trials. PIII studies are done in order to support an NDA, not the other way around.