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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Andrew H who wrote (5958)11/16/1998 11:57:00 PM
From: Vector1  Read Replies (3) of 9719
 
Andrew,
The good news is that approval is all but assured. The fact that Panretin was not approved as a first line treatment is not a huge issue as the docs will make that decision. What concerns me is that the reviewer at the FDA reached the conclusion that Ligand erroneously found evidence of meaningful reduction of KS in half of the responders. The FDA areviewer based his assesment on pictures taken of the patients which must be very difficult to analyse and far less accurate thatn actual inspection. It appears that the FDA was not willing to accept the clinical judgement of the docs who treated the patients. Something does not smell right here. Either the FDA is paraniod or they thought there was some kind of consiracy. My gut is the reviewer suffers from pananoia. Does anyone else think this is strange.
V1
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