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croumagnon

09/04/07 1:56 PM

#4905 RE: DewDiligence #4900

"An unmet medical need generally results in a priority review, whether or not there is a Fast Track designation"

Yes, we all understand that part. However, what you seem to not understand is that Fast Track designation is based on an unmet medical need also. Thus, when a product is designated as good for Fast Track, as is ATryn now, the FDA has implicitely said that, if nothing changes dramatically in the landscape soon, Priority review is nearly guaranteed because they have already classified ATryn as addressing an "unmet medical need"...

Obviously, the 10 guys in the basement that are capping GTCB to pick up cheap shares are hoping that many will agree with your point of view, and they have already started their capping gimmicks with the slowing volume. However, that does not change the fact that Fast Track Designation, whether you want to agree or not, is actually a bigger deal than the market is giving it...