It was always going to be accepted.
6 month PDUFA is piss poor.
Watch the shorts increase and the manipulation continue.
At least SI has changed his dialogue to “potential” approval.
Share price has gone up 14%. Watch it come back down over the next few days/weeks. And before people start banging on about the Nasdaq about to go bananas…it probably won’t.
IMO this is the not the best outcome. FDA must have a bit more to pick apart by needing 6 months.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-36
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