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Re: Regulardoc post# 138120

Thursday, 03/01/2012 2:38:10 PM

Thursday, March 01, 2012 2:38:10 PM

Post# of 257262
Re: Eliquis

I heard about this likelihood about a month ago, but why do you think the market viewed this as a positive?

My guess: Since the FDA did not announce the convening of an advisory panel for Eliquis when it extended the PDUFA date, investors are inferring that there will not be a panel. Whether the lack of a panel is bullish or bearish is debatable, of course; however, when implicit information about the lack of a panel is coincident with a PDUFA extension, as it was in this instance, it’s somewhat more bullish than bearish, IMO.

Moreover, the Eliquis data package in AF/stroke prevention is extremely strong, so it’s reasonable to assume that the PDUFA extension itself is merely procedural—i.e. a consequence of BMY/PFE’s submitting additional data after the NDA filing.

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