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Biotech / Medical : Oscient Pharmaceuticals Corp. (OSCI) -- Ignore unavailable to you. Want to Upgrade?

To: fred hayes who wrote (1124)	1/20/2006 10:45:29 PM
From: fred hayes	Read Replies (1) \| Respond to of 1154

OSCI CC re factive refusal to file for ABS. Sorry, but not anything significant that is new... .................................. CC lead by Steven Rauscher, President and CEO. SR indicted much surprise at rejection. FDA indicated that factive did not exhibit an acceptable risk versus benefit profile, and believed it was not feasible to demonstrate acceptable risk. Will seek path towards approval based on discussion with FDA. Submission includes data on 1,800 of original 7,000 trial patients, plus off label use, resulted in strong supplement for ABS label. Some Q & A stuff: Rash about 2 percent for 5 day treatment, increasing with longer treatment. Partner effect on rejection? Partner focus has been for non-US. Impact "unclear". Dodged questions on specifically what path to approval might be considering extensive data already submitted and negative FDA statements even tho had volunteered an extensive P4 program. OSCI will provide update in March CC.