Actually I haven't seen anything from the FDA that says they don't require another aGVHD trial.
I have seen some broker speculation (from the one who organises the cap raisings) and puts a high value on the share price and lots of posts hoping that they won't and suggestions from SI that maybe they won't. But SI says a lot of things that seem to bend the facts to give investors more hope than perhaps he should.
Anyway apparently Novartis is gone and posters here have moved on.
Just another day of disappointment or speed bump on the road to inevitable success...
Ann: FDAs OTAT Agrees to Primary Endpoint for Back Pain, page-172
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