In my view it will end up being they approve because they can’t possibly justify not approving given there is NO ALTERNATIVE and it is a safe product.
then they will approve it with “clauses” like we wish you to do XYZ.
Which will be a win none the less.
a flat “no we don’t approve” when there is no alternative remotely on the horizon doesn’t compute as a possible outcome
mumtioke times the panel members have basically said “we don’t understand a lot but this is the best we’ve got for now” or words to that effect
even Jorge summing it up with “nobody has suggestions on what other testing could be done so wtf are we still talking for”
Ryoncil: ODAC/FDA Meeting Discussion, page-878
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