This, right here is some quality analysis. I'd give it all 3 lightbulbs if I could.
As much as we want MSB to be the frontrunner, we don't want the Trump and dump effect.
When you combine the above with @dachopper's checklist
https://hotcopper.com.au/threads/will-the-fda-refuse-approval-in-the-face-of-the-favourable-odac-9-versus-1-vote.5634370/page-19?post_id=47489440
@kervio's bayesian forecasts,
see: https://hotcopper.com.au/threads/overwhelming-efficacy-the-stats-required.5579134/?post_id=46800922
@ddwn's summary of what's got us here and what's ahead,
https://hotcopper.com.au/threads/msb-trading-2020-a-new-dawn.5553688/page-4696?post_id=47492008
@Zenox's logic of the discussion outside of what we see between MSB and FDA
See: https://hotcopper.com.au/threads/will-the-fda-refuse-approval-in-the-face-of-the-favourable-odac-9-versus-1-vote.5634370/page-64?post_id=47508280
Also in one of my earlier posts pre ODAC meeting, I highlighted that
label adjustments and requests for trial post-approval in adults is the other likely outcome.
See https://hotcopper.com.au/threads/fda-odac-meeting-material-discussion-analysis.5549415/?post_id=46449348
In another post, I researched FDAs stance on Novel therapies and their thinking around approval, with anexample of a recent approval for a different cell therapy with conditions.
See https://hotcopper.com.au/threads/fda-odac-meeting-material-discussion-analysis.5549415/page-247?post_id=46497669
FDA approval is not a 'Will they grant it?'
but a
'What date before Sep 30 are we getting it?'
I'm picking Tuesday, 29th September, after a trading halt for NASDAQ:MESO with the queuing for MSB the following morning
I've been accumulating when I can in recent times.
Don't get me wrong, an outright FDA rejection, given all of the above, would be a shock. But not an insurmountable one, given everything else to follow after aGHVD and COVID. I will be accumulating in this extremely unlikely scenario.
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This, right here is some quality analysis. I'd give it all 3...
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