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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Miljenko Zuanic who wrote (9520)2/1/2003 12:37:31 PM
From: Vector1  Read Replies (2) of 9719
 
Miljenko, although there are examples of oncology drugs being approved on phase II data the FDA is very uncomfortable with this and the standard is very high. I wouldn't give a 99% likelihood of the FDA approving anything much less a drug without a controlled trial without any insight into the rigor of the trial or insight into the quality of the data. In my judgement there is some risk the FDA will not even accept the application at the end of the 60 day period.

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