Replies to post #596760 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

The nonsensical post is an outcome of oblivion to the 2022 AOO article on the ECA guidance by the FDA Oncology group. Oblivion to the JAMA article also. Hence the confusion and fog in the post.

[hoffmann6383]

The FDA and MHRA accepted the trial design. This discussion is moot. The hedge fund social media army is really scraping the bottom of the barrel with these repeated narratives that are based on nothing but fabrications.

have a good one Ex! by.

[dennisdave]

First of all, you, as I have said, posted a falsehood when you said this:

Besides, the guidance, like others, specifically states that OS is compared to ECAs is not a valid endpoint.

That is not what the FDA Guideline says, the FDA Guideline says

Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival

You turned seldom into never.

More important the Guideline also says this
A. Survival is considered the most reliable cancer endpoint, and when studies can be conducted to adequately assess survival, it is usually the preferred endpoint.
B.

Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival.

But NWBO did not compare its data to externally controlled trials. NWBO compared its data to present Standard Of Care SOC.

Third C. "Demonstration of a statistically significant improvement in overall survival can be considered to be clinically significant if the toxicity profile is acceptable <which in the case of DCVAXL is, being zero> and has often supported new drug approval and as The Danish Dude pointed out ."

45 approvals id'ed where FDA accepted ext. control data in benefit/risk assessment; doing so for many reasons incl. rare nature of the disease, ethical concerns wrt use ofplacebo or no-treatment arm, seriousness of condition, and unmet medical need

[biosectinvestor]

You only linked to guidance. Guidance is not a regulation and the trial was in fact blinded and randomized. The difficulty was the regulator mandated a requirement that depleted the placebo. That is the regulator’s fault. Not the company and not the trial managers. Hence the regulator themselves changed the rules and liberalized the requirements for external control arms, because it was starting to be understood that living treatments like this one and others require more flexibility, and it will also speed new treatments and literally “cures” to patients.

That’s why they methodically did the contemporaneous external control arm using external, fully blinded third-party epidemiological experts, and took it to the regulators for approval beforehand.

The reality is they have much more assurance of likely approval, and most of us do knowing all the details here and that regulatory behavior than any bear. Bears are taking date “guidance”, ignoring the full picture, and insisting on a nonsensical result. Sure, it’s “possible”, sure, dated general guidance that doesn’t fully cover the changes in guidance and thinking and the circumstances of this exact trial SUGGESTS some differences…. But bears are getting their full wad on a really unwise, super risky, guess.

And, in the opinion of informed persons I see, whom I think understand the regulatory process and what else has been approved and why, it seems highly likely to be approved IMHO. Very unlikely, at the end of the day, though they will no doubt point out all kinds of issues, that they won’t make it available given it’s a rare disease, safety record, incredible signs of efficacy, likely will be synergistic with other immune therapies, expands the tools available to doctors and not least but most important, using an ECA indicates excellent increases in survival with hints of potential cure for some increasing potential with more combinations.

Bears are insisting on an absurd outcome only because reputationally and financially, they NEED it.