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Re: nmstav post# 4659

Wednesday, 08/08/2007 6:22:36 PM

Wednesday, August 08, 2007 6:22:36 PM

Post# of 12660
Actually, the negative FDA decision after the positive panel may be the first this this happened in a terminal indication. The agency just yesterday turned down an sNDA for Advair for a larger dosage in COPD, after the advisory panel voted thumbs up in a UNANIMOUS vote. But it wouldn't surprise me at all if the SEC is investigating both the insider sales and the FDA decision and how it played into the hedge fund trades.

I was glad to hear David Miller ask mgmt if they had closed some trial sites after the positive panel vote (and then reopened them after the CR letter). I'm going to take mgmt at its word that it did not close a bunch of sites after the panel meeting, as doing so would certainly have angered the FDA.

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