PTLA plans to submit a BLA in late 2015 seeking accelerated approval based not on clinical outcomes, but rather on restoring FXa levels that have been lowered by taking Xarelto, Eliquis, or Lovenox. The phase-4 (technically phase-3b) trial described above is needed to convert an accelerated approval into a full-fledged FDA approval with a label that includes the ability to treat major bleeding episodes caused by FXa or LMWH anticoagulants.
*Technically, this is a phase-3b trial.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.