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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (9026)	9/1/2003 5:52:50 PM
From: Icebrg	Respond to of 52153

TRENDS IN DEVELOPMENT AND APPROVAL TIMES FOR NEW THERAPEUTICS IN THE UNITED STATES [This is a must-read-and-save article]. Janice M. Reichert Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, Massachussets 02111, USA. janice.reichert@tufts.edu The process of clinical development and regulatory review of new therapeutics in the United States was significantly changed by a number of legislative acts passed in the 1980s and 1990s. These acts were designed to encourage the development of innovative products, especially for rare, serious or life-threatening diseases, and to ensure that patients had timely access to these treatments. To assess the effects of the various modifications to the process, the Tufts Center for the Study of Drug Development analysed clinical development and approval data for 554 therapeutics (504 small molecules, 40 recombinant proteins and 10 monoclonal antibodies) approved in the United States from 1980–2001. Trends in the number of approved products and the clinical development and approval times indicated that the effects of these changes were generally beneficial as of the mid- to late-1990s, but that the gains have not been sustained in the early 2000s. Current efforts by the FDA, and the pharmaceutical and biopharmaceutical industry, to reverse the recent tendency toward fewer new approvals and longer approval times are discussed..... nature.com

To: Icebrg who wrote (9026)	9/2/2003 4:19:55 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

The optimum time for drug licensing But note that the numbers they quote as "typical" deals are lower (at least for late-stage products) than those you would expect to see now. Of course their point still holds if the increase has been across the board from early-stage to late. Biotechs are much less willing to do low-level early stage deals than they used to be. The early-stage deals you see now are either from desperate biotechs trying to keep the doors open, or have numbers more typical of later-stage deals (e.g., epo D from KOSN). Peter