They met and decided at that meeting that they should meet again.
That's the world that this 'drug' is in.
It's a half step but in the right direction. I'm happy the CEO has finally felt he has to act like a CEO. The 'Prof' has grown up finally. That too, is a good sign.
The FDA can only talk/indicate in 'next trial' terms as the previous trial was knocked back by the FDA. They are not going to make comments otherwise or they would confuse and look stupid.
It's back to the MSB projects team for another crack at the FDA. I have all toes and fingers crossed as this same team has delivered nothing yet and no changes in personnel have been announced. SI must think they are the 'dream team' I hope they are not the 'dreaming team'.
It sounds close and there is hope that they pull this off without another trial. Last roll of the dice without major changes in personnel I reckon.
Genius or madman? Not long now!
Happy NewYear! For those that pray - do it!
I will say the emergency use story recently allowed by the FDA does provide a little excitement to this announcement. The toe was dipped in the water!
Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-47
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