NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It was a risk factor. It was a function of running this trial ethically, and allowing patients who wanted the drug to cross over and get the drug if their disease recurred. The reality is, the FDA required that there be a placebo but had not yet changed its rules when this trial kicked off and this trial kicked off long before there was a common understanding of how immune therapies worked, including pseudoprogression and even really before a lot of cell therapy trials had ever started. It was an adaptive trial and the FDA actually prefers that framework with live drugs that are dynamic and which involve learning over the course of the trial.

The reality is, OS is a primary measure of success and PFS is only a proxy measure of OS. PFS has been frequently found not to correlate with OS, hence the FDA reevaluated old approvals last year of immune therapies that were approved conditionally on the basis of PFS because they had not yet proven OS improvements, drugs like Keytruda and Opdivo were reevaluated.

In this case the company properly and scientifically adjusted the trial’s SAP, and they did not have one I understand and filed it, got it approved before unblinding, following FDA rules for that, and they adopted a new FDA rule for external control arms, following FDA rules for that also part of a fully approved SAP via all the relevant regulators including FDA.

You can keep repeating your nonsense and refining your false narrative explanation over and over again. The reality is they followed all rules and regulations, they got significant improvement in OS which is virtually impossible to deny, and we will have to see how regulators react, but the UK regulator, MHRA has allowed them to sell the drug to terminal patients in the UK, a very unusual move if we took your view seriously. Experts around the world have praised the trial and treatment, and you and a few anonymous social media posters continue to say that there is a massive penny stock fraud involving UCLA, Mings College and numerous top research institutions throughout Europe, Canada, the UK and US as well as a Federal Court, the SEC, the regulators.

If hedge funds did not think retail were stupid, they’d ever get away with such a campaign. But they believe that just like with US elections, you can convince people of nonsense and make money doing it.