I try to be pessimistic with this sort of stuff and focus on the negatives:
-Tasley wants out of CHF partnership (wouldn't take much discussion?)
-ARDS is futile (discussion to make sure?)
-Death or departure of exec team members (nothing in the news)
-FDA does agree to use mortality as primary endpoint (too quick a turnaround?)
-Unforeseen manufacturing issue (evaluating damage)
Potential positives are:
-FDA discussion confirms mortality can be used as the primary endpoint (quick turnaround)
-ARDS overwhelming efficacy and a discussion to make sure the FDA will honour that
-GvHD conditionally approved (discussion around conditions)
-Partnership for CHF (too soon imo) or acquisition of tech
-Company restructure/acquisition with a partner
Everything else (CLBP +ve/-ve, GvHD not approved, etc.) could have just been a regular announcement and wouldn't have taken by surprise. It also would have been described as such by the trading halt request.
I doubt Tasly would leave on the back of that data (one of the only things that could reduce CHF mortality is a massive deal guys, the only potential issue is bureaucracy requesting confirmatory trial) without the full report.
Together - it looks like either ARDS futility/overwhelming efficacy or a company structure change, either in the exec or with an acquisition/Tasly leaving.
Happy to have people criticise my lists, let me know what I've missed in each
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