The FDA specifically asked for further clinical trials.
MSB has come up with something different. Hopefully good enough.
You hope or Reg hopes or both?
I don't see why you'd be hoping for an outcome that so far as I can see would require an error or a failure in standards of the FDA to grant a BLA.
Did you applaud loudly the Trump Supreme Court ushering in a new era of Presidential immunity saying oh great now justice can really be done?
Absolutely nothing good can come from a capitulation on good standards to appease the greedy and the undeserving game players that cheat.
That's like wishing cancer well or a Trump supporter their hearts desire.
Makes no sense to me to hope for what you own analysis tells you can't happen - (your own analysis - I thought - told you there wasn't enough data from the study001 to clearly associate the outcomes of that small amount of donors and lots with the outcome) unless you are hoping your analysis is wrong because it's making you miserable.
This wishing well on the profoundly undeserving is not commendable - its like socially going along to get along with those whose values ought be opposed.
Cheats are not, sensibly wished well. Parasites not encouraged to breed. Rubbish piles not celebrated with "my haven't you grown my little beauty". There is such a thing as ill health and poor intent and misbehavior and we aren't Gods looking down with impugnity and indiference on bugs that can't hurt us one way or another those grubby people and practices and low values are possibly futures - worse futures - if we can't tell good from bad, social from anti-social.
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