Not necessarily the statement is for purposes of the initial determination for the trial involving nGBM. There is no such limitation on the diagnosis for rGBM.
For the determination of recurrence the trial was required to be consistent even though it was learned during the course of the trial that the standard method alone was flawed and not valid for pseudoprogression. This is an unfortunate part of the ridiculous formality of trials, that you’d have to continue to diagnose in this manner, in order to remain consistent, knowing, in fact, that you’re getting a false result. This is what shorts are most consistently about. And the company maintained that for purposes of the diagnosis of recurrence for nGBM.
However, once the patients were diagnosed as recurrent, you do not know if additional review of their disease happened, but that seems awfully likely. It would be medical malpractice to diagnose such patients as “recurrent”, when they were not, in fact, recurrent.
There was no original protocol for the rGBM patients, so they will discuss that I am sure with the regulators. However, there is also no reason to doubt the survival results compared to patients with the same or similar diagnosis in trials that happened concurrently.
Further, remember that pseudoprogression difficulty in diagnosis happened in the treated arm, the rGBM patients were getting the standard of care only, so pseudoprogression likely was not an issue and even if some of them are, again, you’re comparing to patients in a standard of care, getting the same exact care, in concurrent trials. No difference.
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