Replies to post #671652 on NorthWest Biotherapeutics Inc (NWBO)

[Margin Buu]

DCVax-L isn’t a placebo. I know your comment will most definitely be forgotten along with all the other wrong statements made on this board but I sincerely hope history remembers you as a naysayer who thought DCVax was a placebo.

The document Flipper highlighted can easily be applied to our treatment so it’s as if our treatment was in the minds of the document writers. No one has claimed every document ever produced applies to DCVax-L, that’s silly.

Probably MHRA approval in the next few months. Fixed that for you. You included your faulty logic in your calculation so your probability percentage is incorrect.

[drugrunner]

Yes the worlds preeminent Oncologist in GBM is treating everyone with a placebo

Poor IC — what an idiot u must be

[User-840664]

<<>>

You are being too generous, I have it at 0.000000

[Garyedward71]

That would be interesting. I wouldn't doubt that more than a few placebos failed in the regards to safety margins. Even with rigorous data collection, number clusters can show up as bonifide scientific results. That is what the P factor measures. A .05 P factor is a 1 in 20 chance of being a random number cluster. Wasn't NWBO's P .001 1 in 1000 and P .005 or 1 in a 1000 and 1 in 500 rolls of dice would the data be a random number cluster. What would you call such placebos that ended up with P factors greater than P .05, Freedy Krugers syndrome.

[User-840664]

Sharing what I saw on a different message board:

<<< We'll see what the real deal is when they repeat the trial with a legitimate, hypothesis test, experimental-control trial. 99.9% of pivotal trials are a experimental-control hypothesis test, which is considered the 'Gold Standard" in such matters.

The historic, unmatched comparators used in the current PIII are good for evaluating snake oils and home-grown remedies -- for cancer therapies .... Get real -- not going to fly.

NWBO will declare bankruptcy as soon as regulators issue a decision that they want a new PIII trial.>>>

Any comments?

[exwannabe]

This board thinks every document ever produced had DCVax in mind.

So true.

The FDA Tissue Agnostic Guidance sates clearly:

For the purpose of this guidance, the term tissue agnostic oncology drug refers to a drug that targets a specific molecular alteration(s)3 (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type.

Specific and "all antigens" are about as different as one can get.

Similarly Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.

This guidance does not address other types of external controls, such as using summary-level estimates instead of patient-level data.

Actually worse though, as t also describes many of the issues with the -L trial.

Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial

Before initiating is not the same as before datalock.

Sponsors must include in their marketing applications relevant patient-level data (i.e., data on each participant and patient in the externally controlled trial), as required under FDA regulations for both the treatment and external control arms

NWBO does not have the patient level data on the ECA. It matters, that is why the FDA says "must include" it.

Plenty more.

[User-840664]

So basically, NWBO did EVERYTHING wrong?