NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

1) in the Risk Factors Section, and the interim analysis in 2017 they focused on OS. Read it.

2) Risk factors are there for a particular reason. They had a plan to address the straightforward issues that I believe even then, had they no route to fix the fact that everyone wanted the drug and crossed over and the technology issue with GBM, I still believe the FDA probably would have approved in some form or fashion;

3) Instead, they explained a plan, long before unblinding, that they were going to update their SAP to address the fact that they no longer had a placebo, but they had all of these patients living very long (even Dr. Liau had said it years ago, and about historical comparisons, and AF made a whole column about it that was very harmful), and they explained they were looking at incredible survival data and no drug of any kind has extended survival for GBM recently, of may hundreds of failed trials, and they did it for newly diagnosed and recurrent GBM. In fact, crossover trials have certain features because you can use patients who crossover as their own placebo measures, which I believe they are still considering doing.

4) these things are documented from the annual meeting transcript before unblinding as well as a PR, buried but on another subject, the year before and lots of conversations of years that are documented here.

5) it’s not manipulated, because they did it before unblinding. It’s completely consistent with FDA guidelines to change the endpoints, as that is documented how to do that and even BP does that from time to time, successfully. The ECA was done on the basis of new guidance and the FDA has been approving other trials using ECA’s and I have no doubt that they discussed it with all the regulators and the foreign regulators even are a bit ahead of the FDA on these matters. The change is also part of the 21st Century Cures Act reforms.

Everything is kosher, but risk factor sections cover anything that could possibly go wrong, so that shareholders have been warned and know there are risks and they can’t bring suit. Their disclosure was not there to announce they were breaking all the rules and doing bad things, contrary to your points.

This is really tiresome HyGro because you tell false narratives constantly.