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Biotech / Medical : Biotech Valuation

CRSP 56.87

-2.2%

3:59 PM EST

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To: Miljenko Zuanic who wrote (3643)	5/1/2001 9:30:46 AM
From: Biomaven	Read Replies (1) of 52153

Clear evidence of a slowdown at the FDA for NME (new molecular entity) approvals: Approval Times (In Months) for NDAs and NMEs Approved Fiscal Years 1988-2000 (Updated 4/24/2001) fda.gov 2000 was still better than 1997, but clearly 1998 and 1999 are now "the good old days." These statistics are also interesting: Active Investigational New Drugs (INDs) at the Close of the Calendar Year - Calendar Years 1986-2000 (Updated 4/24/2001) fda.gov INDs Received Calendar Years 1986-2000 (Updated 4/24/2001) fda.gov So the rate of commercial IND's has been pretty constant, with a slight 1998 peak. Active IND's have been very steady, with a modest secular growth trend. Be interesting to know what % of the IND's have been from biotechs vs. from pharmas, and what % of the IND's are for NME's. About 40% of approvals are for NME's, but approval rates are bound to be higher for the non-NME's and NME's must also have substantially higher attrition. So at a rough guess NME IND's must be well over 50% of all IND's. Peter

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