NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Where's the evidence that the post hoc protocol is FDA approved?? NWBO's SEC filing says it was not. As they said: "There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach."

The crossover was part of the original trial protocol as the rescue method. There was no reason for FDA to change it as patients in cancer trials need rescue medication option. But it also confounded the naïve OS data as clearly stated by the NWBO.

If FDA had "approved" the post hoc protocol, then NWBO would have assurance that the protocol/SAP methodology would have been approvable -- but they said the opposite.

PIP has nothing to do with regulatory approval other than as a pre-requisite for an application to the MHRA. That's it. It does not mean NWBO's post hoc protocol manipulation will be acceptable.