Trial was not a requirement, more evidence was, and that has been provided.
FDA is not always correct- like when they recomended MSB use implantable device end points instead if pain reduction for CLBP trial. Following FDAs advice caused us to miss the primary end point.
The requirement was more evidence.
Compelling evidence has been delivered.
Ex FDA head of a department has seen under the hood, and made a large investment for himself. Writing is on the wall. I think over 90% likelyhood.
2023 The Final Countdown, page-1215
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