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Biotech / Medical : Magainin Pharm (MAGN) -- Ignore unavailable to you. Want to Upgrade?


To: kech who wrote (127)3/29/1998 10:34:00 PM
From: Shlepper  Read Replies (1) | Respond to of 233
 
Tom,

I'll try to get through tomorrow or Tuesday to get the scoop. My gut feeling is that they have all of the data that they need (but maybe not all is machine readable), but need to go back to retrieve (from source documents, etc.) and analyze additional data. I don't think they need to conduct additional tests. If they did, unless it were minimal procedures, would mean more than the 6 month delay they've indicated.

My company works with pharmas in their clinical trials (among many other fields such as transportation and education). The process is quite complex, and the FDA is pretty touchy about their guidelines and standards. I suppose Magainin has enlisted those who know the ropes to get this through. Companies like Guilford hired people from the FDA to gain the expertise on how to get through the process. Sounds like a wise investment - at least it worked for Guilford.

I think the entire market will be tanking this next month, but biotechs - with FDA approval and potential may become the darlings - as the overvalued blue chips take the hit.

Good Luck,

Shep