WTF so got bounced because didn't do trial in children now gets bounced because didn't do adult trial.
If it was known then why didn't MSB comply seems ludicrous, does the FDA even want this to happen be damn sure BP don't.
No issues with potency, manufacturing then why cant they approve for use in children as no other alternative they have shitloads of data this just sucks balls for all those that need this and of course the old LTH.
Nothing to do but go through with the FDA bullshit trial again and wait.
In the meantime, let's hope for better news on heart & chronic pain which is still keeping me in the game.
Cheers & GLTAH
Ann: Update on BLA for Graft Versus Host Disease, page-78
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