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Re: DewDiligence post# 60959

Wednesday, 04/02/2008 2:16:16 AM

Wednesday, April 02, 2008 2:16:16 AM

Post# of 257253
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.

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