Ultimately, what do ppl think will be the outcome of that FDA meeting based on those graphs from a gold standard RCT?
Really, only 2 choices:
1. Likely benefit, no harm. Meets EUA bar for submission. Please submit docs and fast track ODAT meeting for manufacturing.
2. Looks like a strong signal. We need larger study size. Here is the numbers we need for confirmatory P3.
Anyone doing statistical gymnastics trying to claim a cold shutdown from FDA on those stats is being intellectually dishonest as we have sent from some Twitt.
Based on those two realistic options, I don't see how Novartis would justify to its shareholders to sever the deal to save a measly $50M. Once they sever the deal, it will be on those executives' heads for the next decade to justify why they missed out on partnering for the first ever allogenic stem cell treatment. I can't see it happening, if I am intellectually honest with myself, taking out as much shareholder bias as I can.
Ann: Appendix 4C Quarterly Activity Report, page-221
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