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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: CMason who wrote (1115)12/19/1997 9:32:00 AM
From: Dauntless  Respond to of 7041
 
Expedited review is not reserved for life threatening disease states - proof is that Pfizer's Viagra has been accepted in this category.

It is not a clear cut delineation but it does require that there are no other APPROVED drugs - then they consider the side effects. If Zonagen files their NDA before PFE receives approval, they will likely also considered under expedited review.



To: CMason who wrote (1115)12/19/1997 9:44:00 PM
From: Claud B  Read Replies (1) | Respond to of 7041
 
The FDA has granted Pfizer expedited review on Viagra.
Theirs also is not a life or death drug. The rules by which
the FDA operates is that if they grant expedited review status
to one drug, they will give the same expedited review to a similar
or competing drug, provided the NDA is filed within six months
of the original (in this case, Viagra) application.

Claud


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