Replies to post #389312 on NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

Boy, where do I begin? When you are on the defensive you use a lot of words and build false ideas out of whole cloth! You have put many words into my mouth that I have never written nor intended as straw men, and then proceed to try to knock them down. I will highlight some of those areas below:

You’ve got it backwards. NWBO is not “excluding” anyone from the trial, the indication for which a license applies has been redefined. They luckily have an inclusive trial that covers both GBM and Glioma. NWBO never defined Glioblastoma and would not be doing so now. A license is for Glioblastoma as defined by the FDA.

False, NWBO, as in all trials, does exclude some from entering the trial! The trial - not "luckily" _ but by design includes some of those that are now defined as GBM and Gliomas, because they were all thought to be defined as GBM when the trial started. I never said that NWBO was "defining" Glioblastoma - not then, not now! What they did do was define the parameters of the trial (not the license - why did you drag that in here??)

You’ve got it completely backwards and are suggesting NWBO is doing something wrong by being prepared to answer the questions that the regulator will necessarily need to ask.

You seem to like the phrase "you've got it completely backwards." you seem to use it a lot - but never back it up with specifics that I wrote. Here again you build another straw man argument. I NEVER suggested that NWBO is "doing something wrong," nor am I complaining about being prepared to answer regulators questions. where did you get that from I wrote??

That it happens to show more efficacy is merely an ancillary benefit. You seem to keep implying, even after you contradictorily say it is the WHO, that NWBO is driving that conversation. That is false. It is the scientific community and ultimately the FDA that will be driving the licensing process for a drug for “Glioblastoma”, as defined by the medical community, not NWBO. The regulator will drive that conversation, and they will see apparently a mechanism that is confirmed.

Here again, another straw man argument. You do this a lot. I did not "imply" that WHO or NWBO is "driving that conversation." I said nothing whatsoever on that score. In fact the only "conversation" on this matter is here on this bulletin board. Furthermore, I never mentioned "licensing" - all that was being discussed was the trial vis a vis the redefinition of GBM by the WHO.

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It seems to be upsetting people that by accident it actually HELPS the trial by showing more efficacy.

"Upsetting people" has got nothing to do with it. The basic question is whether some new definition made after the trial by some 3rd party, that the trial did not and could not have addressed, should have any impact on how the trial is evaluated.

It’s not like the FDA will then bend the new definition to fit the drug. Nor is it likely that they will ignore the results of the trial. I know many people in all sides of debates related to drug licensing like to villainize the FDA and regulators, but that is simply not how these things work.

Now you're speculating on what the FDA will do and making assumptions you have no basis for. No "bending" needed. All they need do (if they wish to approve what they deem a successful trial) is approve the treatment for both GBM under the new definition and for Gliomas as well, as the trial included both cancers.

And trying to flip it around like the company is driving this redefinition to benefit itself is clearly, flatly incorrect. The FDA will be driving that analysis.

Another straw man! I never claimed "the company is driving this redefinition to benefit itself"! All this was, just a BB discussion.

It’s not a crutch. The science has been updated by the broader community and regulatory agencies and it just happens to favor this trial. It could just as easily have gone a different direction. It didn’t. Has nothing to do with anything NWBO is doing to create any “benefit”. It’s nonsense to see it that way. It has nothing to do with them, it just happens to make them look better because the science going on elsewhere confirms the science that this trial is based upon. It’s the best of all possible worlds.

It’s CONFIRMATION by the larger world, of the science in this treatment, not a change of anything by NWBO. The larger world, by other means has defined GBM a certain way, and it confirms the mechanism that was predicted by this trial. Period. And the regulator will be the one driving the analysis. It’s why they reserve the right to scrutinize SAP’s. If it had gone the other way, then NWBO would be looking at a treatment primarily for gliomas. Either way it would be useful, but a license for a particular indication must be driven by the definition of that indication. Anything else makes no sense.

GIVE ME A BREAK!