Two problems, First, Optune's interim trial data was fully blinded, met all the trial protocols and was NOT data dredged. It was unblinded for filing for approval.
That was clear enough for the FDA to approve Optune.
Second, the Optune five year nGBM trial extension was published -- it was not used for FDA approval as Optune was already approved.
This is unlike what NWBO did in their current trial. NWBO tossed out the original primary endpoint that failed. NWBO manipulated the trial protocol, comparator, endpoints and SAP, rGBM endpoint was not in the original protocol -- it is a different indication. The NWBO trial was designed as a naïve GBM trial. The rGBM arm was post hoc data dredged and is at best going to be considered "exploratory."
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