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Biotech / Medical : Texas Biotech (TXB) -- Ignore unavailable to you. Want to Upgrade?


To: Bill Wexler who wrote (703)6/9/1998 9:14:00 AM
From: Sleepman  Read Replies (1) | Respond to of 834
 
It still is not clear why the FDA panel does not feel that Novastan is approvable. In spite of having good data, the FDA may have problems with applications based only on procedural issues.
I repeat my question, where is your data that show that the drug is not effective and more dangerous than other anticoagulants? If you can show that, you have a case, so make it. Dan



To: Bill Wexler who wrote (703)6/9/1998 7:19:00 PM
From: James Perry  Read Replies (1) | Respond to of 834
 
The FDA may pose a temporary impediment, but I am unprepared to assume the existence of such a belief on their part.