NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Another point to make Schnauzer regarding the cross over arm.

You ask...

when you reach PFS point why would you discount the spread by improving the control.

Please note that the PFS wouldn’t change in this case because control would have already contributed their “event” to the count before moving into the patient moved into the cross over arm. So in a sense, they are done contributing as a control patient.

Now we'll get to see data on how patients perform as a recurrent GBM patient in the cross over arm (as I stated before). There’s enough data out there to show how rGBM usually does.. so all the control patients that cross over will now be treatment patients.

Anyway, PFS is absolutely the best choice for this ph. III trial. It’s very useful when an early halt could be on the table. In fact, one of the advantages of PFS as outlined in the “Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics” is that it is “NOT confounded by subsequent therapy.” - subsequent therapy, in this case, being DCVax-L.

This same document also states that The FDA and the applicant should agree prospectively on the following items:

•The study design

•The definition of progression

•The data to be recorded on the case report form (CRF)

•The SAP

•The methodology for handling missing data and censoring methods

•The operating procedures of an independent endpoint review committee (IRC), if applicable


http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071590.pdf

I’d submit that the FDA was consulted with and agreed to the design of this Phase 3 trial.

And what do you mean by this point?

If you buy the argument that game over at PFS point, then explain why anyone would bother switching control to L at that point as it offers no benefit.

At a PFS event, especially if it comes early, would suggest to the patient he was in the control cohort. Why on earth wouldn’t that patient then want to jump with both feet into the crossover arm? I'd submit that's probably one of the selling points to this trial… no one wants to receive the placebo, so with this trial, at least those that do eventually receive the vaccine. Unfortunately, they do as a recurrent GBM patient.