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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-471

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  1. 1,975 Posts.
    lightbulb Created with Sketch. 501
    How is it an interpretation issue? The FDA cannot say "will approve". Why go through the application process if they could just do that now?
    The use of the word "May" is reasonable considering we still have to go through the motions.

    "May" suggests what data has been provided already is indicative of possible AA.
    I agree regarding your point re: timing against the shares being awkward. Though the timing of the meeting is on point to previous with previous guidance.

    You'd have to also agree that I'm general saying something to effect of "how could they not support any AA application" is pretty dang stupid.
 
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