Kacy all credit to you in uncovering/highlighting this. It should be your thread (I posted above). As more cautious members have pointed out, its very unlikely to overturn the decision. The FDA was clearly prepared to overturn ODAC for the first time in a positive vote ever with a CRL. But it does throw another question on the decision. That tips the balance on the type A meeting likelihood and an approval, particularly if this somehow hit the press in good fashion, with GvHD suffering kids as the backdrop to the FDA's over-turning of an expert advisory committee on tarnished representation from their own dissenting committee member.
@Sailor1 an@JackTahoe please tread very carefully with the FDA. I know you already despise me Jack (for casually criticising the present administration), but see above that and perhaps use some of the more informed points like other one-armed approvals for GvHD, the precedence in the ODAC postive ruling overturn, the MSB presenations at ODAC and simply ask questions, rather than asserting any improprietary at the FDA. I am sure you won't recognising it will only worsen MSB's chances....
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