Biotech Values

[DewDiligence]

Two balls and no strikes!

[This is a repost of the penultimate paragraph in #8495, which was mostly a post about GENR rather than GTCB. Thus, I’ve extracted the GTCB portion so it can be added to the updated GTCB ReadMeFirst file.]

GTCB’s planned pivotal trial of goat antithrombin (with pooled prior results) vs “prospective historical” plasma-derived antithrombin is not like any clinical trial I have ever seen.

In baseball terms, the ability to use the pooled prior data is like stepping up to home plate with a count of two balls and no strikes.

If GTCB had an SPA to boot, it would be like stepping up to the plate with a 3-0 count. Since they have evidently decided to forego an SPA (please see #msg-5607789), I guess we’ll have to settle for a 2-0 count.

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Just to be clear: the positive developments with the U.S. ATryn trial design are gratifying, but they do not increase the probability of a favorable outcome with the EMEA. GTCB longs still have to sweat that one out.