RE:RE:RE:RE:RE:RE:RE:How does Accelerated Approval work what does this have to dpo with ONCY... we're beyond phase II meetings... mBC we've now run IND213, and Bracelet-1.
oh wait, yup, now we're planning a third Phase II... ALL this when the FDA 6 years ago granted ONCY a SPA for running a Phase III using Pela + Pax vs Pax alone.
Go and check the company presentation slide deck from Feb 2018...
Page 3
Positive feedback from FDA (EOP2) and EMA (FAL)
One phase 3 study of 450 patients.
Granted Fast Track Designation
Addressing unmet medical need
Expedited and rolling review
154,000+ metastatic breast cancer (mBC) patients > $ Multi Billion
Partnership with Adlai Nortye o Licensing fee and milestones for mBC of
$21.2M Milestone payments of USD $65.4M
Double digit royalty
Hmmm, we had our end of phase II meeting, and FDA said, run a trial with 450 patients... That was 6 and a half years ago... ONCY also had a partner, and royalty milestone payments of 21 million would have been due on treating first Phase III patient.
BUT thanks for copying and pasting about BTD Noteable... now give us aYOUR realistic timeline for AA.