Replies to post #512792 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thank you for highlighting this aspect of the P3 that is often misunderstood. The FDA, the P3 investigators, and others have recently spoken on this topic.

“Crossover was necessary for feasibility and ethical reasons:

—Necessary for enrollment and retention of patients in an era when immune therapies are not yet generally viewed as promising for cancer

—Important to justify all patients undergoing invasive leukapheresis procedure

—No benefit to placebo patients unless they could receive their autologous product made from the leukapheresis”


"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug”—Richard Pazdur, MD

Richard Pazdur, M.D. is the director of the FDA's
Oncology Center of Excellence (OCE), which
leverages the combined skills of the FDA's
regulatory scientists and reviewers with expertise in
drugs, biologics and devices to expedite the
development of novel cancer products. In his role as
director of the OCE, Pazdur is responsible for
leading the effort to develop and execute an
integrated regulatory approach to enhance the
cross-center coordination of oncology product
clinical review.

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

[biosectinvestor]

SAP was revised before unblinding, and the issues were resolved. They may ultimately and certainly will discuss all the relevant details, by the at the end of the day, given other precedents and this particular case and changes to policies, I believe that 1) this is an orphan indication; 2) a serious and deadly disease for which progress is much needed and has been long coming; 3) it has immense and broad support from patients, non-profit brain tumor orgs and the doctors that treat patients in this area; and 4) it has delivered undeniable survival benefits to patients and to the bottom line costs of care as well (and can be delivered in a doctors office) as, and this is extremely important, it has limited to no side effects.

They will certainly weigh all the issues thoroughly, as they always do with every drug and the previously approved drugs also has issues and challenges. But at the end of the day, there will, in my opinion, be an enthusiastic regulatory approval.

IMHO, this is a serious breakthrough and looks to offer immense benefits to expanding combination therapies that very possibly will rush what many expect to be potential cures to a larger and larger proportion of patients who may have many different tumors and cancer types. Additionally, dendritic cells have promising other potential uses beyond oncology.

This will be a huge new area of research and a new tool set with which to work. I do not believe that regulators will likely say no.

But yeah, they will discuss all of it including criticisms. That’s their job. But they won’t make up facts or stories about the trial to advance nonsense claims about why it must be rejected. That, I am confident, will not happen.

[Roman516]

No problems

"One problem. NWBO's OS is confounded questioning the validity of the data. NWBO said so, and regulators could easily reject the results as invalid."

should be stated, "no problems, NWBO's OS data is successful, there are confounding factors that still rebuke the truth that DCVax-L works.

When the OS data results are real and well received by doctors, scientist, and professionals but disagreed by confounding false statements there is no association regarding the truth and fiction since they are both independent from each other. Therefore, NWBO's DCVax-L prevails and should continue to move forward.