Replies to post #175865 on Biotech Values

[DewDiligence]

PTLA presents final phase-3 data on Annexa-A* in Eliquis reversal:

http://finance.yahoo.com/news/portola-bristol-myers-squibb-pfizer-124500432.html

…following the administration of a bolus of andexanet alfa, the anticoagulant activity of apixaban, as measured by anti-Factor Xa activity, was reversed by 93.5 percent (p<0.0001). Following completion of the two-hour continuous infusion of andexanet alfa, the anticoagulant activity of apixaban remained significantly reversed, by 92.7 percent (p<0.0001).

PTLA plans to seek FDA Accelerated Approval based on this trial and a similar one for Xarelto reversal (#msg-109811606) using the FXa level as a surrogate endpoint. Conversion to approval will then require a clinical-outcomes study. The regulatory plan is similar in the EU, as far as I know.

Although my view of this program has softened to some degree, I remain somewhat skeptical for the reasons mentioned in #msg-99274632. The share price is +8% today.

*F/k/a andexanet alfa.