Biotech Values

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PTLA hopes they can get FDA approval for PRT-4445 based a single 100-200-patient PD study and that efficacy studies in bleeding patients can be done on a post-marketing basis. I think they’re dreaming.

Where did you see or hear that? To me it looks like they're planning a Phase III. Am I misinterpreting this?...

We've now completed a series of discussions with the FDA including just yesterday and end the Phase 2 meeting regarding the clinical and manufacturing path forward for andexanet alfa. We conducted these meetings yesterday with our academic leaders for the program and with our collaborators from J&J, Bayer and BMS Pfizer.

Based on these meetings we continue to plan for an expedited approval pathway for andexanet alfa that will allow us to bring this important product to the market as soon as possible.

The final agreement with the FDA is pending submission of the Phase 3 protocol which we plan to submit to the FDA later this year in anticipation of investigating these studies in the first half of 2014.

For andexanet alfa we expect the core data from our ongoing Phase 2 study with the Factor Xa inhibitor antidote this year XARELTO and to report data from additional Phase 2 study of andexanet alfa and other Factor Xa inhibitors including edoxaban, betrixaban, and low molecular heparin, enoxaparin. After our recent discussions with the FDA, we are moving forward to initiate our Phase 3 clinical study in andexanet alfa planned for the first half of 2014.

http://seekingalpha.com/article/1641092-portola-pharmaceuticals-ceo-discusses-2q-2013-results-earnings-call-transcript?source=email_rt_article_readmore