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Replies to #89359 on Biotech Values
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DewDiligence

01/21/10 4:17 PM

#89365 RE: genisi #89359

Savella: Do you recall FRX’s boast that they were going to out-detail LLY and PFE because FRX is purportedly more “focused” on fibromyalgia than those much larger companies? Based on the sales numbers, it doesn’t look like they’re succeeding.
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DewDiligence

08/20/10 6:21 AM

#101968 RE: genisi #89359

FDA panel splits vote on LLY’s Cymblata for pain:

http://www.reuters.com/article/idCNN1925181020100819

The panel voted 8-5 in favor on approval for back pain but 9-4 against approval for osteoarthritis.

FDA label expansion for Cymbalta won’t help LLY much because the drug goes off-patent in the US in 2013. Moreover, the 3-year Hatch-Waxman marketing exclusivity for a new indication won’t matter in this case.