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Saturday, April 25, 2020 7:47:44 PM
If past trial designs (like NWBO's very old trial) are inadequate, they are unlikely to result in approvals.
You seem to think that means the FDA should ignore all its procedures, ignore bad trial design, and approve dcvax regardless.
I think it means taking everything that has been learned the last 15 years (including the points you mention), design new protocols and endpoints, and run a new trial that actually does prove efficacy.
And as usual, any comparison to Optune is irrelevant (to FDA approval, not to patients) as it was approved as a medical device.
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