Agree, an ADCOM would seem very unlikely at this point. I'm not as confident about the read through to a black box warning at this point. Seems like CEO has been thinking about potential of a black-box around NDD and not one for DD, based on the last interview I listened to. This has traded sideways for so long it's hard to imagine it ever trading up again, even with a clean label, LOL.
Lots of applications getting held up by inspections, and idea if FGEN needs one? Seems like in this case it should be pretty straightforward if they do.
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