The FDA basically gambled that MSB would actually have the wherewithal to continue with the process and to spend the time and money (and to hire top guns like Dr Krause) to stand a real chance of finally getting a product through after an initial CRL. That would NOT be a sure thing for alot of other companies (looking at you, Athersys...), and even for MSB, it's meant a few more cap raises and other near misses (to say nothing of suffering the slings and arrows of the Tom Richardsons of the world).
I don't mind the FDA doing what it's supposed to do by putting in place strict requirements for companies to get approvals...but DO NOT gaslight companies and put them at risk of financial devastation with your petty little games because you cannot get your act together enough to actually look out for patients and the advancement of science--even if that means taking away some of your Big Pharma benefactors' monopoly on healthcare.
Ugh, just thinking of those sneering FDA creeps going after MSB during the ODAC makes by blood boil. What a bunch of absolute tossers.
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