PTLA—The last sentence of your post encapsulates the problem: A trial design that is marginally ok for a Big Pharma is not necessarily ok for a small biotech firm going it alone. As iwfal said, Betrixaban is going to be an “interesting” advisory panel. At even money, I would bet against a positive vote.
You didn’t comment on the other two bullet points I cited in #msg-89329551. I would have expected you to criticize the spin PTLA is promulgating about Betrixaban’s purportedly superior PK for the indication in question.
This arrangement is similar to the deals PTLA previously struck for phase-2 testing of PRT-4445 as an antidote for Eliquis (#msg-81069705) and Xarelto (#msg-84232022); no money changes hands, but Daiichi Sankyo will provide Edoxaban free of charge for the phase-2 trial.
Edoxaban, which goes by the brand name Lixiana in Japan, is similar to PTLA’s own FXa inhibitor, Betrixaban, insofar as it’s late to market (except in Japan, where it was approved in 2010 [#msg-48661173]) and it is not well-differentiated from Eliquis and Xarelto.
PTLA’s phase-3 Betrixaban trial has to hit p<0.01 to be deemed a success as the sole phase-3 trial in the program, according to today’s BioCentury webcast.