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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?


To: James Silverman who wrote (686)1/8/1998 7:44:00 PM
From: John McCarthy  Respond to of 887
 
James -

Is there *any* chance we could goto the FDA - at their
bequest - and not withstanding the ODAC blowup?

Did/is CEPH(SP?) in this posture now. (I realize the indications/
drugs are much different).

Regards,

John



To: James Silverman who wrote (686)1/8/1998 8:52:00 PM
From: tnsaf  Read Replies (1) | Respond to of 887
 
I must not have made it clear that MTSL's comment of "not particularly negative" was about the affect on Chiron.

Regarding approval this year: the FDA does not always follow the advice of an advisory committiee, as in the case of Anesta's Atiq. I'm hoping that if DEPO had an agreement with the FDA about what was required for approval and if they have met those requirements, the ODAC rejection would be overridden. I recall that DepoCyte was going to be approved by the end of the year if an ODAC meeting could not be scheduled. I'm waiting to see.

Jason