Longfellow, while I agree largely with what you're saying, I believe that I expect the company will declare the intent to file BLA's, or whatever the appropriate document is, with all of the regulators.
I've seen many TLD statements that tried to put the best picture possible on results, but admitted that either they'd discuss how to proceed with the regulators, or admitted further trials would need to be done, rather than a firm statement that they planned to submit for approval.
There is no doubt in my mind that if they had it to do over again, with all the know today, a far different trial would emerge, all goals would be met, and it would be done in less than half the time this trial took, and considerably lower costs. That's not saying the trial was a failure, it's saying that much was learned during the course of the trial, and a new trial would be based on what they learned.
Gary
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