NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

You've done an excellent job explaining what NWBO's thinking and situation may be but then under your scenario the FDA is either just indifferent and obtuse or trying to hinder NWBO.

Why do I say that?

Because this Phase 3 trial is for patients who have a terminal illness that is seldom if ever cured by SOC. Simply put, they are dead either way.

Risk can and should be viewed differently for patients who are dead either way. That does not mean that just any risk is acceptable but the risk you were describing? Seriously?

And yet here the FDA sits, acting as NWBO were peddling snake oil for baldness and are thus preventing additional patients from having access to the trial and pushing NWBO to the brink of insolvency so that as with DNDN there may end up being no widely available new treatment at all because the company was too shot up by the time it reached the end of the line.

This might explain why LP added those particular directors but if so they've done a poor job of either lobbying FDA or creating political pressure that will force FDA to act.

I work in local government and I know that when an elected official starts fussing about a particular thing we do what they want right away even if we resent it and even if we have to bend the rules or to delay other things or just do them due to resources being diverted.

Having relatives in the federal government current and retired I can say that things are not that different.

A lot of people were hoping that something good could come out of Beau Biden's death and the Cancer Moonshot would serve to light a fire under FDA's posterior that would get a lot more treatments for cancer available much faster.

Even if NWBO had to work entirely behind the scenes there is no visible evidence that anything was at least done to either convince FDA or get politicians to convince them that they should work with companies trying to provide help for patients with essentiallyincurable diseases and use a different yardstick when it comes to measuring risk for those patients.

Maybe NWBO is too weak and small to get political help and maybe BP was pushing in the opposite direction. But the fact remains that the FD, under your scenario is at least indifferent if not hostile to NWBO.