NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The point of the new reforms at the FDA is to allow for companies to learn about new treatments during the course of their trials and adjust. Of course that has been also a part of this trial for a long time as it was an adaptive trial.

You know perfectly well why PFS and OS were debated about and why they came down for OS in the end. These are not measures that are at odds fundamentally. Most articles explain that PFS or recurrence of the cancer, is a SURROGATE or alternative measure for what they really want for all trials at the FDA, and that is longer survival, or OS. The reason companies use PFS is to get the result FASTER.

The problem, as you know and have known for a very long time, is that they had something called Pseudoprogression, or false progression, and that this has become a thing now known about immunotherapies, but at the time they originally designed the trial, may not have seemed a critical issue or even an issue they knew about. The difference also here is that the only way to measure progression was via a scan, and immune inflammation, or the action of the vaccine, can and often looks like progression for a while.

Scrapping PFS for OS is not actually a negative thing when the reason one uses PFS is as a SURROGATE MEASURE, and often a flawed measure for OS, or survival. We see that some other immune therapies approved purely on PFS, have not given increased survival to any significant degree. Those drugs are the drugs of the largest pharmaceutical companies and one, Keytruda, is expected to eventually reach 19 Billion in revenues a year despite that unfortunate reality. In this case, it looks like we at last have a potential drug that may substantially increase survival. The FDA just did a review of those other drugs and they were at risk of having some of their approvals revoked for lack of a survival benefit, but the agency decided that despite their lack of effect on survival, there was still a benefit from administering the drugs.

Trying to suggest the change to SURVIVAL, and gaining longer term data on a trial that involves a disease with an otherwise very short life span, is a negative, as a long, is quite an interesting investment premise. Could you explain that one a bit more? I'd like to know what the benefit of that would be for a long investor?