Replies to post #9112 on Biotech Values

[DewDiligence]

Re: Separate EMEA documents on antithrombin and bioequivalence:

Thanks, Elmono. The sections of the antithrombin document most relevant to ATryn are 2.1.1 and 2.2. As far as I know, GTCB has complied with all of the listed requirements, especially the requirement that the number of studied patients be >=12. (GTCB submitted efficacy data for 14 patients and safety data for an even larger number.)

Regarding the bioequivalence document you cited in #9106, I do not find anything unusual or surprising there. The document does convey the immense complexity of bringing a new protein drug to market, but I think most readers of this board are aware of that.

These documents do not alter my assessment of a 75% chance of no new clinical trials for ATryn as part of the EMEA’s review. I’d be interested in your own evaluation of this. Regards, Dew