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ariadndndough

05/20/13 9:43 AM

#161333 RE: biotech jim #161326

biotech jim. thanks for posting that. is this the first we heard of this?

i thought next mourning impairment was not issue here?



good article here

http://www.fiercebiotech.com/story/fda-mercks-sleep-drug-suvorexant-effective-safety-issues-draw-heavy-flak/2013-05-20
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DewDiligence

05/20/13 12:25 PM

#161344 RE: biotech jim #161326

FDA briefing docs on MRK’s suvorexant:
http://t.co/JvMtGEQRIO

Updated Reuters piece (background info added):
http://in.reuters.com/article/2013/05/20/us-fda-merck-idINBRE94J0DP20130520
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DewDiligence

05/20/13 5:18 PM

#161396 RE: biotech jim #161326

There is no magic bullet for insomnia—i.e. any drug that keeps you asleep for 8+ hours in going to leave some degree of hangover. The FDA is being too tough in this regard, IMO.