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Biotech / Medical : Alfacell (ACEL) -- Ignore unavailable to you. Want to Upgrade?


To: Tom DuBois who wrote (1410)6/23/1998 11:39:00 AM
From: Greg Kevorkian  Read Replies (1) | Respond to of 1533
 
The pre meeting with the FDA in August-Sept and the yes or no to file the NDA.
If they get a yes, I feel confident that the approval is a very strong possibility.
Again just based on quality of life we should be in. Gemzar got approved on that basis.
I was also told, and if anyone has other info please post it, that no CANCER drug that has gone through P3
was turned down for approval. From what I understand there are app 6 P3 studies
for solid cell tumors and Alfacell is involved in 2. Pancreatic and Meso. Again if someone has other
info please post. I have to stay a believer or go nuts or sell everything!
G