NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

No, NWBO stopped the trial recruiting with the FDA hold and did not continue after the hold was released. NWBO never has communicated the reason for the trial hold -- looks like it was related to the screening and recruiting. From NWBO's SEC filings, at the time of the FDA partial hold they had already recruited 331 of the planned 348. After the hold was lifted they chose to end recruiting and no more patients were added.

The FDA placed the partial trial hold not EU or German regulators. IT was FDA's view of the trial deficiencies that precipitated the recruiting hold. And mysteriously, NWBO has repeatedly avoided reporting the cause of the hold which they clearly knew. Raises questions as to the deficiency and how FDA will respond to the data filing.

Regulators had nothing to do with the pseudo-progression issue, it was NWBO that made the decision -- they tossed out the failed PFS primary endpoint. NWBO has again posted in their SEC filing, it was making the trial changes at risk, without regulator approvals.

Adding the post hoc data dredged rGBM is of particular risk, it is was unplanned, not approved as part of the original protocol, n=64 very small, trial was designed as a naive GBM patient trial.