FDA meeting Press Release

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rccola335
Posts: 305
Joined: Sat Sep 28, 2019 10:00 pm

Re: FDA meeting Press Release

Post by rccola335 » Wed Dec 18, 2019 11:56 pm

i think a phase 3 approval is a no brainer - assumed this once the fast track was designated - was hoping for an early approval - this will decrease the stock price just in time for board members to get their stock options for the year

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: FDA meeting Press Release

Post by biopearl123 » Thu Dec 19, 2019 12:04 am

rccola, I don't see why the FDA should feel compelled to grant AA without some period of time to evaluate whatever was presented at the meeting. I am not sure that the jury isn't still out. bp

rccola335
Posts: 305
Joined: Sat Sep 28, 2019 10:00 pm

Re: FDA meeting Press Release

Post by rccola335 » Thu Dec 19, 2019 12:20 am

Unmet need
- these patients have no hope - so if there ever was an indication for a phase 4 this would be it - maybe we can catch a break for once

bucbeard
Posts: 80
Joined: Wed Jul 25, 2018 12:30 am

Re: FDA meeting Press Release

Post by bucbeard » Thu Dec 19, 2019 12:59 pm

Agreed rccola and BP. This treatment and situation screams for an Accelerated Approval tied to a Phase III (IV) trial.
Last edited by bucbeard on Sun Dec 22, 2019 11:44 am, edited 1 time in total.

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