NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

I don’t believe the External Control Arm (ECA) is a problem with the FDA either. The FDA were the ones who mandated the crossover option for all of the patients in the DCVax-L Phase III clinical trial.

A total lie (the second sentence, first clause is your opinion of course).

From the SAP in the JAMA paper (if you believe it):

Such a large percentage of patients made use of the crossover option in the Protocol that the original control arm became substantially depleted and insufficient for OS analyses within the Trial. When the Trial began in 2007, per the demand of investigators and patients it was necessary to include a crossover option in the Protocol in order to recruit and retain patients.

Further, when designed it was a P2 not designed to establish OS. And the primary endpoint was not affected.

And as far as this statement by you:

According to the recent 10-K, NWBio has been talking with about 6 CDMOs, strategically located throughout the US, and now they are poised to submit regulatory applications to the FDA and Health Canada, in the upcoming months.

As they are presently looking fior a CDMO they are not even close to submitting. This is very basic, the CDMO needs plenty of time to be ready, and that is not months.