Thursday, July 15, 2021 12:37:24 PM
They can’t license a product based upon an outdated notion of GBM.
The FDA does not need to do that! The trial was set up for what we then called GBM, but now relabeled by the WHO so that some of those in the trial are now labeled GBM, while others in the trial are now labeled "XYZ." Well its really simple. If trial is shown to be a success, it is a success for the combined groups of GBM plus XYZ. Then there is no reason that the FDA could not approve exactly that - in the new nomenclature, for both the (new) GBM and the XYZ on the label. Nothing outdated about this!
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