Replies to post #773037 on NorthWest Biotherapeutics Inc (NWBO)

[KRISGO]

So are you indirectly suggesting that efficacy is the reason the MHRA hasn’t approved it yet? If that’s the case, why haven’t they just rejected it outright? Are there still any patients alive who took the red pill? And what about the five-year survival claims—are you saying that’s also misleading?

[skitahoe]

EX. one of the biggest flaws in trials as you describe them is the benefit to those with long term benefits. If the K-M curves were identical right down to the point where 75% of patients passed on, but the remaining 25% just remained alive, while only 5% of the control were alive a year later, the benefit should be clear, but many trial protocols don't look out that far. Once past 50% it's like there is no benefit at all.

I'm not saying that's the case here, I believe we're seeing benefits well before 50%, but the biggest benefit is far more people living longer than if on the SOC. Even if it's only 13% that's over 1.5 times the 5% that's observed on the SOC.

I believe that the regulators know how much better it can be with the addition of Keytruda and/or Poly-ICLC, even if it's in a much earlier phased trial. Why wait for it when at least Keytruda should be available off label until further trials make label mods effective.

Gary

[KRISGO]

When it comes to the science, I admit my due diligence is limited—my approach is more grounded in logic and observation. In my opinion, if efficacy were truly the main issue and there wasn’t reasonable confidence in the treatment’s effectiveness, it wouldn’t still be presented as a leading option for GBM patients in the UK. Especially in cases where patients are uncertain about which treatment path to take, doctors wouldn’t recommend it—particularly for those who can’t afford it or are relying on platforms like GoFundMe to pay for care.

[meirluc]

Well, Ex, the 64 who initially received the red pill (just SOC) but then
received the blue pill (DCVax-L) after progression, had an mOS that was even
somewhat longer than the mOS of the 233 patients who received the blue pill
(DCVax-L) from the get go. Ranking the mOS of the four major groups
on the basis of their treatment (or no treatment) with DCVax-L and the time that
such treatment was dispensed, I came up with the following observations.

1. The longest mOS belongs to the group of 64 crossover patients who received DCVax-L
after progression and most probably were initially less sick than the remaining 35
patients in their group who never received DCVax-L and did rather poorly. Those 64
crossovers were on the average somewhat more robust and more likely to have had
even with just SOC, a slightly longer than average mOS.

2. The 233 Treatment patients who received DCVax-L shortly after chemoradiation had
an mOS of 19.3 months that I estimate was a few months shorter than that the mOS
of the 64 crossovers,

3. The ECAs only received the red pill (SOC) and their mOS was 2.5 months shorter than the
mOS of the 233 treatment patients (19.3 vs.16.5 months).


3. 28-29 of the 35 original permanent placebos remained in the trial (6-7 dropped out) and the
mOS of that group was dismal (per Dr. Liau). I believe they were the sickest 1/3 of the group
of 99 and therefore would have no longer received much benefit from DCVax-L . I am guessing
that such patients would have received salvage therapies. I estimate that the mOS of that
group was even well below the 16.8 months of the ECAs.