NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It is true they got accelerated approvals for many of the PD1 PD-L1 blockers, but a few years later the FDA had to reassess the accelerated approvals for a few of the indications because they never proved a survival benefit. There is actually something called pseudoresponse, where it looks like it has prevented recurrence but it hasn’t really.

In some cases, the shrinkage was still deemed an improvement in quality of life, and the approvals were not revoked. But in some instances, they were not. Not specifically to any specific drug, I just recall the debate and concern, that there was a lack of survival benefit and severe side effects for a very expensive set of drugs. So there was, in fact, a later re-evaluation.

It would be horrible and ironic if the alternative to that was a non-approval if a drug that unequivocally extends survival, and is not just easily tolerable, but has virtually no side-effects, is easy to dispense at a doctor’s office, cheaply, and has patients living 5, 12, 21+ years for a disease that is pretty much an 8-16 month death sentence. I just don’t see the result that bears claim is likely.

Plus you have NIH throwing millions at UCLA because if it’s research on this treatment. You have MHRA bending over backwards to enable the company to commercially manufacture the drug and make it available on a compassionate basis not just during the trial, but after publication of the successful results that bears claim mean the opposite.

It seems not very useful to compare the ability of big pharma to force approval of drugs that are important but certainly not slam dunks just because they have regulatory capture, and for some to imply that means DCVax-L is lesser. It’s definitely not lesser by any stretch of the imagination. The adjuvant and combination trials appear likely to forever put a nail in that argument soon.

So let’s not forget that this happened:

https://www.onclive.com/view/fda-will-reassess-6-immunotherapy-accelerated-approvals

https://www.investopedia.com/terms/r/regulatory-capture.asp