Replies to post #741090 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Do you have anything to support the "futility halt recommendation". Seems like the trial continued.

To correct the wording, the DSMB recommended a futility finding. Per US law, the sponsor, NWBO, decides if the trial can continue. But the FDA will decide if that precludes enrollment of new patients and would issue a hold if they decide to.. As far as evidence, what we know is:

. An efficacy IA was conducted in 2015 (per the JAMA paper). NWBO disclosed it would happen, but never said a word about it later.

. The data presented at NYAS was clear that futility would be seen. It does not matter if the reason was psPD or not.

. The FDA in such a case would follow the law and allow the trial to continue if no safety issues were present. But they would not allow new enrollments as it would be unethical to have patients sign a consent (which in the trial happened at initial screening). This action by the FDA can be seen in the CVM case that was almost identical.

. Despite this being the core thesis of shorts, NWBO has never disclosed the reason despite there being no reason not to do so.

. LP is on record saying after the hold was issued that they wanted to restart enrollment "soon". If the reason was for any good news, NWBO would not say this.

Now, some dot connecting:

. NWBO went dark on the IA because even though is is legal not to disclose such, if you disclose the IA happened it can be "lying by omission" to not disclose the negative story. See the case Anders posted repeatedly where the exact issue was decided in Court.

. LP wanted the trial enrollment to resume because they were trying to change the endpoint to OS. The FDA disallowed this because the trial had already performed an IA, thus the endpoint change would still no be part of a "well run trial".

. As a factual note, NWBO implied in PRs in late 2016 that the trial was ending with planned 211(?) PFS events. Then later when that passed that it would end with 2 more OS events. Then it would end whenever. As a theory, I take it as obvious that with the trial already formally busted they were having the DSMB (or some such) perform analysis to see what was working. This would allow them to properly say the trial was still blinded despite knowing what was going on. If you doubt the legality, you can find many PRs by respected BPs that announce results while also saying the trial is ongoing and still blinded.

You can believe what you want. LP could always deny any of this, and does not.

[iclight]

First there is no such thing as FOIA request to a company.

That's not what I said. The company absolutely has the ability to limit FOIA request information as this POS has.

From the protocol:

One of the two planned interim efficacy analysis was conducted in March 2015 after 56.4% of subjects had completed 6 months follow up.

Now go submit an FDA FOIA request regarding FDA halt of the trial after March 2015 IA. You will get a call from the FDA indicating that the company does not wish to disclose the information. You can ask the FDA rep if this is a material event and they will confirm it is not.

You should look up the definition of "recommendation" since English is apparently your second language.

Also from the original protocol:

Based on its findings at either regularly scheduled or emergency meetings, the DMC may recommend continuing, stopping, or altering the trial. At its regular meetings, the DMC will review data on recruitment and on both safety and efficacy endpoints. The DMC will see data separated by treatment group. Possible reasons for a recommendation by the DMC to stop the trial are an unacceptable excess of AE among patients treated with DCVax-Brain, an excess of
primary endpoint events in the treatment cohort, low power to show a beneficial effect of DCVax-Brain, and insufficient enrollment into the study.

We know it's not a excess AE issue. DCVax is as safe (and efficacious) as placebo. We know it's not insufficient enrollment as they already expanded the trial.

That leaves an excess of primary endpoint events in the treatment cohort, low power to show a beneficial effect of DCVax-Brain. And obviously it wasn't stopped because it works so well.