Did you ever see any statement or announcement to the effect that Mesoblast had held negotiations with the FDA and they no longer wanted Mesoblast to conduct another randomized trial in children and/or adults? In all his webcasts and interviews is there one where he specifically says that?
Now I've certainly seen multiple enthusiastic Mesoblast supporters claiming that. @stockrock who seems well respected posted exactly that and got 5oTU. His post was to the effect that if the FDA accepted the resubmission of the BLA as "complete" then that meant they had dropped the request or need for another trial. When I questioned where that idea came from I was howled down. Other posters pointed to the second part of the sentence by saying that the FDA "just wanted more data", not higher quality data and not data "generated" from the existing data of a flawed and deficient trial.
So if SI has never said that Mesoblast had held negotiations with the FDA and they specifically said they no longer wanted another trial, where did that rumour come from, becasue it seemed to be everywhere and widely believed? John Hester said he understood that was the case, but where did he get that impression from? There's only one possible source that he would trust. The other party to the discussion with the FDA, Mesoblast. The penny doesn't seem to have dropped for John Hester that he might have been "misinformed" by someone as to what was actually said. Instead he still clings to the idea that the FDA has gone back on commitment, that more than likely, NEVER existed.
Mesoblast has been sued for misleading and overstating the likelihood of approval, and settled out of court. This time they've let others do the overstating and misleading, but it's clear the company must still have been the source.
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