NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

One problem, NWBO trial is NOT an Adaptive trial. From the clinicaltrials.gov :
"Study Type : Interventional (Clinical Trial)"
Sorry interventional trials are NOT for manipulation of the protocol post hoc.

Let's see how long it takes this inept management to complete a complex application for approval. Explain the cause of the stop, the protocol, comparator, endpoint and SAP changes, why they tossed out the PFS primary endpoint they failed to meet. Adding the data dredged post hoc recurrent GBM arm out of a naïve GBM trial, the company declared confounding of PFS and naïve OS, the challenges of an external comparator, etc. Then Advent must be vetted by FDA too. Personalized vaccines are operational challenges from patient to lab to patient.

DCVax-L is NOT the Standard of care -- NCI's definition of Standard of Care: "Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. " DCVax-L can't possibly meet this requirements -- Not even approved, can't be widely used by HCPs, etc. DCvax-L is a comparator in the NCI trial, NOT SoC.