NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

* The P3 trial randomized 233 to -L and 99 to placebo. => Yes so what? The trial's designed primary endpoint failed badly and the OS secondary almost certainly did. OS cant be met without PFS extension so BS. OS is x3 better then SOC

* After an efficacy IA that informed them that the trial was sucking they changed plans.=> Speculation and a lie. You have zero evidence for your rehashed lie. They did amend the SAP without knowledge of any disclosed data. But you have a patent on making BS up computer guy.

* They waited for OS between the arms to save the trial, but that failed.=> No OS did not fail. OS is x3 better than SOC

* The change to ECA was post hoc as they already knew key information about endpoints even though the trial was still blinded.=> No the new SAP with ECA comparison was submitted to the FDA 3 years before datalock. So another lie,.

* The ECA was not designed prior to commencing the trial as the FDA says in their guidance.=> You keep refusing to quote the FDA something you and "Doclogic" have in common. Claiming what the FDA requires but somehow never able to quote the FDA on it.

* The ECA does not have patient level data as the FDA calls for in regulations => That is correct however the FDA has not made a final decision on ECA. Moreover, it would be illogical for the FDA to NOT allow average ECA patient data, that would block medical trials on lethal diseases. I will quote the American Brain Tumor Association on this

An FDA proposal to require the inclusion of patient-level data in marketing applications may prevent the use of external controls for some rare diseases, the American Brain Tumor Association said in their comment. “[I]ndividual patient-level data (IPD) is not always available for many cancers and other rare diseases,” they wrote. “This is due to many barriers that interfere with data sharing in healthcare.”

* The bias introduced by extent of resection is a serious issue and they have no data to adjust for this.=> No its not. The primary endpoint is OS and the second is PFS. Brain tumor shrinkage is therefore irrelevant for determining if the medical trial met its endpoints

* CMC can be challenging as the trial spanned decades and the proposed facility was not used in the trial. GMP is not sufficient, one must have equivalent process. => The process of producing DCVAXL has never changed. GMP facilities may come and go the process is still the same and can even be enhanced in quality. Your assertion is another huge BS here.