thanks noted
Just as an aside and looking back at the ODAC - I think MES did themselves no favours at all introducing the previous trials (265, 275 and 280) - caused more questions and confusion from what I can tell.
Might also have made this Accelerated Approval pathway they now have to go down somewhat more easy if all they offered up for priority review was protocol 001.
MSB to dispute FDA finding in Type A meeting, page-317
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