Replies to post #217385 on Biotech Values

[GD]

I guess CHMP has the right to stick to the books and FDA did the
right thing to prove Bevyxxa, IMO. I have a question about patents
of Bevyxxa, Can PTLA get new patents from new indications from
future FDA approvals, like atrial fibrillation and hip or knee
replacement surgery?

[DewDiligence]

Oops—make that Betrixaban (not Bextrixaban).

[DewDiligence]

PTLA -28%/AH on CC disclosure that FDA may require an additional trial for approval of Andexxa (FXa antidote).

I predicted such an outcome five years ago (#msg-91053501).

This is PTLA’s 4Q17 PR:
https://finance.yahoo.com/news/portola-pharmaceuticals-reports-fourth-quarter-210500661.html

[DewDiligence]

CHMP actions today (including PTLA/Betrixaban rejection):

https://t.co/GUWZw6WRBd

[DewDiligence]

PTLA -7%—CHMP extends review of Ondexxa (proposed EU brand name for Andexxa) to 2/28/19:

https://globenewswire.com/news-release/2018/12/11/1665009/0/en/CHMP-Extends-Review-Period-for-Portola-Pharmaceuticals-Ondexxya-andexanet-alfa.html

The CHMP informed Portola yesterday that it will provide a list of outstanding questions related to the data package the Company submitted for Ondexxya last quarter, which will require additional responses from the Company. The preliminary timetable provided to the Company by the CHMP sets a deadline of January 29, 2019 for responses to the questions followed by a 30-day assessment period for the CHMP to review the Company’s responses.