Biotech Values

[iwfal]

ZGEN - Thrombin vs Fibrin

Thrombin stand-alone is intended for cases, such as certain types of neurosurgery, where the physician desires a more gradual onset of clotting than that provided by standard fibrin sealants

(Before responding note that my original post incorrectly assumed that EMEA required a head to head trial (see notes below). But regardless this is probably a useful discussion, just less useful.)

Thanks. The general principle is what I expected. That sometimes being better (as Fibrin is as hemostatic agent) is worse. Like sometimes a quick setting glue is worse. But, and here is the interesting question - how do you design a trial to thread that needle? Is it longer time in surgery (because the surgeon has to go back and redo mis-sets). ... ?

FWIW - The literature points to renal surgery as being a focal point for Thrombin use as a sort of rinse (and that sort of inexact placement wouldn't be well suited to fibrin sealants). But I am far from sure of my interpretation of the literature.

FWIW2 - the ZGEN cc yesterday made two points (both triggered by questions asked by David Miller - so hat tip to him):

a) ZGEN has been pursuing taking Thrombin back from Bayer since long before the EMEA decision - e.g. they made reference to consultants being brought in by ZGEN to look at the various strategic options. My guess is that the EMEA decision made the final negotiations with Bayer much easier - but the point is ZGEN clearly wanted this. It was not forced by the EMEA decision.

b) I was incorrect yesterday in my post in assuming that EMEA wants a head to head trial against Fibrin. That was my interpretation of the original PR that ZGEN put out announcing the rejection of the EMEA filing - but the correct interpretation, as clarified last night, is that the EMEA has guidance on hemostatic agents and the descriptor for that guidance is 'Fibrin sealants'. But the guidance is applicable to all hemostatic agents - so thrombin could actually be tested against some lesser hemostatic agent, just that the protocol has to follow the guidance.