LeftYahoo.
Appreciate your views as always.thank you.
My question: The initial IND approved by FDA for the 55 patient open label trial…. Why and with what conscious did the FDA say to MSB to go ahead knowing that they would NEVER approve the BLA because it’s not controlled trial ?
I’m sure if they said to MSB that you can do the trial but you will never be approved … so best you do an Adult trial if you want approval in kids … I’m sure MSB would have followed that partway.. they then string along MSB for 2 years .. without saying “guys .. we notice your not doing a controlled trial in Adults … you better to do it “.
Instead accept the BLA .. let’s go to Singapore to find out More about Stem cells ( all the time knowing no chance of approval).
Someone has not been transparent here … for reasons that we come out one day ( as the truth has a funny way of coming out).
GLTAH
LeftYahoo.Appreciate your views as always.thank you.My question:...
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