Yes that's right, "may" !!!
How much better is that to the alternative answer to the question asked? What were the alternatives that the FDA could have given?
IMO " may" is as good as the FDA would say.
Never have I seen them say "will" as that would undermine the BLA review process.
They could have agreed to the AA pathway and demanded a trial based on surrogate endpoint. That would take years to complete.
Then they could have been really negative and said the indication was not suitable for AA and a trial would be required with long term survival of x years as a primary end point.
What's team Mesoblast doing?
Filling in BLAs
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-97
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