Biotech Values

[DewDiligence]

>Now that the cc is complete I have no idea what to think<

I see what you mean—the CC covered a lot of ground and made it seem like GTC was placed in a Catch-22 on some of the cited issues. For instance, the extra filtration step was added at the EMEA’s behest, but now the Agency says, “Sorry, your patients weren’t tested with that step in the process.”

Where GTC may be culpable to some degree is in allowing surgery cases and pregnancies to be mixed into one trial. Simpler is usually better in clinical trials.

>My confused thoughts are: 1) Forget the EMEA - they aren't going to change their decision<

Probably true, although GTC has the right to request a different rapporteur in the reexamination. I give the appeal a 5% chance at best.

>2)This process is too complex for a surgical setting (isn't that essentially what they are saying?)<

Not exactly—it’s the difference in dosing between the pregnancy cases and the surgery cases that caused the problem. However, none of this has anything to do with ATryn per se; the same variation in dosing would occur with plasma-derived antithrombin.

>3)What does this (2) mean in terms of the FDA trial?<

GTC will have to find out (and fast) if mixing pregnancies and surgeries could potentially be a problem with the FDA.