FDA meeting Press Release
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- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Re: FDA meeting Press Release
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
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Re: FDA meeting Press Release
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
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
- 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
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.