Portola Phramaceuticals (PTLA)

[pistol1p]

"These highly statistically significant Phase 3 ANNEXA-A data demonstrate that andexanet alfa has the potential to be the first agent approved as a universal Factor Xa inhibitor antidote. We anticipate filing a Biologics License Application with the FDA for Accelerated Approval at the end of 2015," said John T. Curnutte, M.D., Ph.D., executive vice president of research and development for Portola.

The two small phase 3 trials are going well and the 1st trial reported good results described above. But both of the small phase 3 trials have been on health volunteers. Will and how will Portola test andexanet alfa on actual patients with critical bleeds on anticoagulation therapy?

In the statement above, made by the executive vice president, it says that the filing with the FDA for the BLA will not happen for a year.

The need is certainly there for this product, but what will the FDA require for approval?