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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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