NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I agree with much of what you say, I won’t go too deep in any point, but I do not think it was necessarily the “regulators”. They knew they were going to switch to survival, or OS. The downside of survival is a trial needs to go a really long time to get the data. The primary reason to use PFS is because it allows for quicker decisions if you see tumor shrinkage, not because that leads to increases in survival but because it is believed generally to be a surrogate measure of survival, a proxy for survival, and it is HOPED that PFS will lead to extended survival but it often does not.

The FDA just re-reviewed and undid some approvals for the big immunotherapies like the various checkpoint inhibitors, in other cases they accepted there was no survival benefit but decided to leave the approval because they believed patients benefitted anyway.

It shows actually how flexible the premier regulator in the world, as seen by other regulators, has actually become.