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11/17/22 9:09 PM

#534595 RE: Judge Smails 40 #534587

Adaptive trial by virtue of the fact that GBM is an orphan disease with the Statistical Analysis Plan and it's endpoints being pre-specified and submitted to regulators before unblinding, the fact is that the peer-reviewed journal concluded ( reviewed by over 70 top neuro surgeons and cancer specialists ), "
Results were clinically meaningful and statistically significant with an extension of overall survival in both nGBM and rGBM. "Treatment with DCVax-L also had an excellent safety profile and noteworthy tails of long-term survival curves".
They don't have to like it but they do have to accept that these groundbreaking results will lead to approvals :-)