NorthWest Biotherapeutics Inc (NWBO)

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S.P.A. .

Responding to AF's 'concern' that NWBO does not have a S.P.A.

The Facts.

*A special protocol assessment is not available for trials that have already started.
*Moreover, a phase three trial protocol assessment is worked out post-phase 2 and pre-phase 3.

In the case of NWBO, a S.P.A. was not available (nor necessary) because the trial morphed into a phase 3 trial from a phase 2 trial.

When a company has already started enrollment, their protocol can still be evaluated by the FDA (CDER and CBER), but procedurally, no S.P.A. will be issued. This quirk in the FDA protocol evaluation procedure as it relates to NWBO's trial timeline does not lower NWBO's chances to ultimately be approved, nor does it raise red flags -- it is simply a different procedural route.