Whytee on the 1st possibility , if the FDA were luke warm .. that it terrible verses FDA saying a simple NO .
Admittedly FDA are not stem cell experts and so they asked Adcomm to make the call .. the call was 9-1
So ALL this drama would have been avoided 8 years ago .. if the FDA had stuck to there RCT policy... the rest is history.
Unfortunately for the stakeholders ... the FDA have washed there hands from there decision to accept an open label IRD 8 years ago vs insisting on RCT.
I feel for SI and the stakeholders.
GLTAH.
Whytee on the 1st possibility , if the FDA were luke warm .....
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