NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

She did not "kill" AA. She will not be informed regarding efficacy results until the trial is "complete."

You seem to misunderstand accelerated approval. It means you get conditional approval on a surrogate endpoint until a confirmatory trial is run, it does not, as your posts seem to suggest, always mean approval earlier on in the trial on the primary endpoint -- although it can additionally mean that.

If you think an interim analysis cannot invoke an action by the FDA and/or recommendation by the DMC to terminate the trial early for efficacy which might be countered judiciously by a cautious CRO in Europe and/or the United States, you do not understand the flexibility and understanding oversight committees and/or regulatory agencies are willing to prescribe for immunotherapy trials, and particularly vaccine immunotherapy trials (with particularly long tails) which the FDA drafted supplemental guidelines for in 2011.

Again, LP is blinded until the trial is complete, and she intends to keep you blinded until the trial is complete. Under these circumstances, goings on may still be afoot. Trials can still end early.

I still believe we may have hit the first interim mid June to early July, the screening suspension started around August 1st, and if that is the case, as long as the CROs filed something nearly on time (Sept/Oct), we are on pace for a possible AA at the end of February give or take a month or so. IMHO.

You can believe anything you like.