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Biotech / Medical : Biotech Valuation

CRSP 55.11

-2.6%

Nov 7 9:30 AM EST

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To: Doc Bones who wrote (7105)	9/25/2002 8:42:56 AM
From: quidditch	Read Replies (2) of 52153

FDA Comm'r and Iressa re. Actimmune: First, from GS this morning, further noise that we will soon have an FDA Comm'r in waiting: We believe President Bush could nominate Mark McClellan for FDA Commissioner by the end of this week. McClellan has the backing of the pharmaceutical and biotech industries, and is also likely to be approved by Sen. Kennedy (D-MA), whose committee must confirm the nomination before it is sent to the full Senate for passage. We believe McClellan is likely to be confirmed before Congress adjourns for the year in mid-October. With a Commissioner in place, FDA is more likely to pursue reforms that could improve approval times and eliminate unnecessary regulation, in our view. Unrelated question: can the Advisory Panel vote supporting Iressa for third tier treatment based on 10% tumor shrinkage and 36% patients showing improved lung symptoms be taken, in an entirely different disease/pharmaceutical context, taken as a positive sign for actimmune (where survival rates seemed to increase but lung function indicia did not hit primary endpoints)? Or, should Iressa news be considered neutral for ITMN? quid

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