GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: Priority Review

>…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"<

You’re making the mistake biotech neophytes often make: thinking the FDA behaves like a single person. In reality, whoever made the decision to grant ATryn a Fast Track designation may not have anything to do with the decision whether to grant the ATryn BLA a priority review.

FWIW, I’d say the ATryn BLA has a 55% chance of getting a priority review. The decision may depend, in part, on what Talecris does with Thrombate between now and when the FDA decides on ATryn priority review in May or June. Having a looming competitor may spur Talecris to get more product out and to talk up its recent safety enhancements.