NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Honestly, I'm a bit confused. Wasn't the trial designed, approved, and run under regulatory guidance to the extent, that data and periodic checks and verifications were made throughout?

The various regulators review the trial to insure that patients are treated ethically. They are not insuring that the drug is safe or effective at that time. It would be an obvious chciken/egg issue if otherwise.

As it is with interim reviews to assess safety and benefit compared to standard care?

The IA are run by the sponsor (indirectly through a DSMB). The FDA (or other RAs) are not involved in that.

Are we saying that in the three years BTW DL and Jama, that the regulators were not involved, as part of a verification process, so as to avoid having to do it as an afterthought long after? The latter seems to be a weapon of mass bureaucratic slow walking if I've understood correctly imo.

After the trial was run it was up to NWBO to submit the MAA,. Neither the MHRA, FDA, PEI, Heath Canada nor any other government agency was in the process. The only agency that has a program to try to speed up the process at that stage is the FDA (RTOR).

BTW, you do know that the MHRA gets most of their funding from BP. And an additional several million from your favorite OS developer, Mr Gates.