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Replies to #60959 on Biotech Values
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genisi

04/02/08 2:16 AM

#60960 RE: DewDiligence #60959

No. I think an approvable letter is more likely. I don't think the FDA will be comfortable with laropiprant safety yet (there are no long-term usage data for it).

BTW, after looking here the data we're discussing were pulled from these 4 trials started on Jun. 2007:

http://clinicaltrials.gov/ct2/show/NCT00479882?term=Cordaptive+MK-0524B&rank=1

I think that the Niaspan used in the trial was not the more recently introduced version (lower flushing incidence) so another point that can narrow the difference.