Replies to post #708597 on NorthWest Biotherapeutics Inc (NWBO)

[XMaster2023]

The JOURNAL ARTICLE has over 70 Coauthors who typically are doctors and or researchers with PHD’s degrees. All agree the trial achieved statistical significance when compared to the current standard of care. Please provide your comparable credentials and we longs will listen to you. If your a journalist and have no Advanced Degree and or you are simply paid to bash NWBO. Please find another venue to spread your BULLSHIT.

[exwannabe]

* The ECA was not designed prior to commencing the trial as the FDA says in their guidance.=> You keep refusing to quote the FDA something you and "Doclogic" have in common. Claiming what the FDA requires but somehow never able to quote the FDA on it.

Has been quoted and cited many times. From FDA guidance on external control arms:

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

* The change to ECA was post hoc as they already knew key information about endpoints even though the trial was still blinded.=> No the new SAP with ECA comparison was submitted to the FDA 3 years before datalock. So another lie,.

The sponsor can know results of efficacy IAs prior to datalock and unblinding. We know as a hard fact that an efficacy IA was performed in 2015. We know for a fact that the IA would have produced a reccomendation on go or nogo. We know as a fact the IA saw the unblinded PFS data that was trending hard the wong way and should have been expected to yield a futility rec. We know as a fact NWBO would have been informed of any rec. We know as fact that the FDA placed a hold on the trial shortly after.

If t was a futility rec, which anybody with the slightes common sense would assume, then NWBO had the information that makes the endpoint change post hic despite being blinded.

* The P3 trial randomized 233 to -L and 99 to placebo. => Yes so what? The trial's designed primary endpoint failed badly and the OS secondary almost certainly did. OS cant be met without PFS extension so BS. OS is x3 better then SOC

The designed in OS was between the 233 that were randomized to -L and 99 that were randomized to placebo. That failed badly. Some will try to deny it, but the numbers look that way and the fact that NWBO has buried the endpoint (and it still is an endpoint in the SAP) makes it clear.

If the 233 vs 99 OS was trending well (even if not stat sig) the PPS would have seen a huge increase as it would be evidence of efficacy (even if not suitable for approval).

Longs can make excuses for the failure n the OS within the randomized controlled trial but that does not change reality.

* The ECA does not have patient level data as the FDA calls for in regulations => That is correct however the FDA has not made a final decision on ECA. Moreover, it would be illogical for the FDA to NOT allow average ECA patient data, that would block medical trials on lethal diseases. I will quote the American Brain Tumor Association on this ..

You continue to argue it would make trials impossible to stick with this, but when I note the recent GBM P3 that will use patient level data for the ECA you say that doe not matter. Regardless, it still is the FDA view and to cll them illogical shows a complete lack of understanding for what the issue is and why they so. It also ignores it is in FDA regulations, not just the guidance.

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 [21 CFR 314.50(f) and 601.2], for both the treatment and external control arm