Replies to post #522835 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

MHRA signed off on the trial. DCVax will soon be approved.

The MHRA approved a plan to run two P2s using ECAs. This has been reasonably common for decades.

The PIP trials are not pivotal. The standard of proof needed is far different.

The ECA will be defined in advance of the trials being run. Not after finding out randomized endpoints failed.

When planned in advance they could use selection criterion that can be matched to ECAs.

It will not be the same SAP.

[HyGro]

Yes, MHRA signed off on the trial 16 years ago when the original protocol. NWBO has repeatedly stated in their SEC filings that the new protocol has not been approved by any regulators and was done at risk.