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FDA meeting Press Release
Posted: Wed Dec 18, 2019 11:08 pm
by biopearl123
Re: FDA meeting Press Release
Posted: Wed Dec 18, 2019 11:56 pm
by rccola335
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
Re: FDA meeting Press Release
Posted: Thu Dec 19, 2019 12:04 am
by biopearl123
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
Re: FDA meeting Press Release
Posted: Thu Dec 19, 2019 12:20 am
by rccola335
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
Re: FDA meeting Press Release
Posted: Thu Dec 19, 2019 12:59 pm
by bucbeard
Agreed rccola and BP. This treatment and situation screams for an Accelerated Approval tied to a Phase III (IV) trial.