FDA does not over-rule positive ODAC decisions, page-55

Well good luck everyone. Very surprised by today's sell down, more people reducing risk than those putting on ahead of announcement - strange how they held off until today (announcement could have come earlier). Now we are in the laps of the FDA. From stats above and other factors it would be remarkeable if they did not approve.

My opinion matters not (unless you are trading the US tonight) but I think as Wombat or someone said on another thread, statistical assessment aside, the FDA knows there is a randomised trial in ARDS for REM-L ongoing. The very thing they have been crying out for re COVID-19 treatments. To approve GvHD does not impede that trial (the decision on GvHD will be based on the merits of GvHD efficacy) but not approving it rather does. Imagine if they knock back GvHD for kids, despite shown efficacy and ODAC approval, and then MSB/NIH have a successful ARDS outcome for REM-L. The ARDS decision is kind of out of their hands, GvHD is not. They can hardly deny ARDS for REM-L if clear efficacy is shown in one of the most rigidly controlled ramdomised study I have seen, but would then look pretty stupid having denied GvHD when many of the anti-inflammatory actions overlap.

Just too much pointing to an FDA GvHD approval, I am confident not because of bravado, simply logic and past FDA behaviour. Calling the stock market is hard, but calling that is not.