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Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?

To: D White who wrote (360)7/13/1998 11:32:00 PM
From: John Metcalf  Read Replies (1) | Respond to of 717
 
As I remember, one of the "minor" issues wasn't so minor -- it was chemical stability (shelf life) which had not been demonstrated to the satisfaction of the FDA. In addition to proving safety and efficacy, the company must show that they can deliver a consistent quality product from a CGMP facility.

Can anyone correct my memory, or comment on Pharmacyclics' progress?



To: D White who wrote (360)8/20/1998 12:29:00 PM
From: mauser96  Respond to of 717
 
In March 1997 the FDA requested additional information concerning stability. By it's nature such a study takes time, and the delay was expected to be a minimum of 18 months. That means we should be hearing from the company soon if the compound is stable. If not maybe they will quitely let the subject die.


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