I reckon the FDA breathed a HUGE sign of relief. They didn't want to be responsible for this decision, whichever way it went, that much is clear.
They really kind of sandbagged MSB, here though, throwing a TON of mud at the product, their trials, their results. But the FDA can now say, with an incredibly straight face, that they did NOT go easy on MSB. They kept their thumb off the scale.
"It got put through RIGOUROUS grilling from a panel of experts, and in their wisdom, they recommended to approve it. So who are we to reverse that decision? What the AdComm wants, the AdComm gets."
The two absolutely most telling moments of the entire night were:
(1) the complete B.S. surrounding the valid question on the panel re: the Ruxolitnib trial. The FDA rep that jumped in to take that bullet to the face, flailing and sputtering, made a complete a*s of herself, and made clear that the FDA was not really playing fair here; and
(2) the first mum of the young football player, who broke down in tears, and had everyone else sobbing, too. Heart breaking.
It must have felt so good to the panel to smack the FDA and give a voting "hug" to the docs and patients with this decision.
At the end, maybe this is the FDA's extreme reaction to Hydroxychlorquine and Remdesivir, and issues that have been raised about its competency as a result. If they are saying you are too soft? Go too hard. That will shut them up.
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