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biomaven0

10/08/10 2:41 PM

#105905 RE: DFRAI #105890

have you considered novel or sci-fi writing?



Seems like cogent non-fiction to me ...

Teva has no obligation to keep MNTA shareholders informed on the details of their application.

I assume it is in fact a judgment call by the FDA on whether Teva have met the 5 conditions for sameness. If it is indeed a judgment call, then Teva not unexpectedly is publicly calling it their way, but at the end of the day it's the FDA that will be making the call. If the FDA says "no" (and the longer we wait the more likely that is), then my guess is that it's a one to two year delay.

I really don't see that we have any sensible way to handicap the FDA decision here. My gut says it's a tossup with maybe an edge in favor of Teva.

Peter