NorthWest Biotherapeutics Inc (NWBO)

[jammyjames]

"The problem I have with this is:
If mgmt believes we need a change in FDA policy to improve the likeliness of success. Nwbo is something less confident without that change despite their ravings about not seeing life longevity in a trial like this before. These 2 things seem to be at odds with each other. I've felt for a long time that they are afraid to complete and submit the trial while others here seem to argue."

Not necessarily at odds when youfactor in the cross over and that 90% of patients received DCVax-L

"He mentioned there's a new policy down at the FDA they're waiting to have SOC from other trials to be used against our treatment patients to help the statistical significance. And that they're waiting for the FDA to implement that new policy. And this new policy might be useful to NWBO."

It will interesting to hear what this is. I've always thought it would be useful to have a standard database complied by the regulatory bodies for different cancers which anonymously lists the outcome of patients on SOC. That database contains explicit information about the more common variables that go into inclusion/exclusion criteria (i.e age,sex,KPS score, extent of resection etc.). That database can be sampled from by companies running onco-trials using the same inclusion/exclusion criteria as their own and used as part of the evidence for drug efficacy. Would for sure help with stat problems arising from cross over and the ethical issues of recruiting patients into a placebo arm. Note that this would be no substitute for a concurrent control arm but could be used as extra supportive evidence which would for sure help companies like NWBO out.