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Re: HyGro post# 710566

Saturday, 08/03/2024 2:38:39 PM

Saturday, August 03, 2024 2:38:39 PM

Post# of 823223
Please HyGro - not only was NWBO not guilty of violating FDA guidelines
for oncology comparators, it was the FDA itself that was complicit in
changing the original trial guidelines by mandating that all the patients
that have progressed, be given the opportunity to be treated with DCVax-L.

Since about 2/3 of the progressors crossed over, the trial lost its control
arm and had to resort to ECAs as comparators. We can therefore blame
the FDA for changing its own guidelines.

Thank you FDA for changing your own guidelines. Without your initiative
we would never have known DCVax's stunning efficacy for rGBM patients.
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