NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

First of all, you've changed the subject.

I never commented on trial length. Yes, BP has no time for tying up their money for a long trial measuring OS, so yeah, they'd probably not be involved in validating this kind of technology. Their tendency is to let the small guys take all the risk with new technologies and then they buy the drug if it's successful.

I would expect that MOST people would know that already.

The length of the trial had to do with a few factors including the financial crisis in 2008, so yeah, BP typically has steady income, even during downturns, and usually they also don't put trials on hold. Not really a statement on capacities of management nor the validity of the clinical trial, in fact.

And again, about "complete", the comment was not about how long the trial went but on changing the endpoints. And yes, some BP trials have gone through something similar in terms of updating their SAP because they learned something during the trial that made a different measure a more effective and better measure of impact.

I don't think anyone else really questions, reasonably, that measuring OS is not objectively a much more solid, certain and better measure than the surrogate measure of OS by way of PFS. Since the FDA wants OS, and PFS is a surrogate measure intended to get at a faster and more expedient result, validated frequently later by OS data on a phase 4 trial, when a company just basically goes all the way out and measures OS, which takes a long time in the case of oncology, where a drug is effective, and where a company is small and accumulates patients over a long time, the result is still likely viewed as valid and superior, in fact, to an expedient trial that measured a surrogate end point that may or may not be a valid surrogate for OS in that particular case. And let's not forget the phenomenon of pseudoresponse.

https://radiopaedia.org/articles/tumour-pseudoresponse?lang=us

Tumor pseudoresponse, also known just as pseudoresponse, refers to the phenomenon of tumors appearing to respond to a specific treatment on imaging criteria when the lesion actually remains stable or has even progressed.