He was super cautious in the CC. Didn't say that the FDA had changed the goalposts, in spite of being asked directly for his opinion on that. Didn't say he would or wouldn't consider continuing the EAP, said they'd "like to...", but NO commitment. Clearly hedging all his bets.
Thankfully, it's only 45 days or so till an update.
But does ANYONE trust what the FDA will say re: this new trial, that they won't find some other reason to knock MSB back? We cannot be less than a year to 18 months from another PDUFA date on AGVHD in any event.
Over that time, I don't see the average punter coming anywhere NEAR MSB until after we have an actual approval in hand, and I have a hard time envisioning any partners taking a plunge when they appear to be radioactive to the FDA. Indeed, there is a good argument that MSB just doesn't have what it takes to convince the FDA any of its products should be approved. If you cannot get approval for dying under-12 kids, why will it be any different, in the next 2-3 years, for back-pain sufferers, LVAD bleeders, or Crohne's disease victims?
I will almost certainly continue to hold, but I doubt I will even try to further average down. At some point, the old axiom of "throwing good money after bad" has to kick in, and I think this is that point. Let's see if the next meeting causes me to question that decision, however.
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