NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

So if you’re invoking UroGen as a parallel, what you’re actually doing is confirming the path NWBO is already on:

Yes I am. These situations have enough parallels to put to bed the idea that trials with serious issues can and do make it to serious consideration by regulatory bodies.

The DCVax trial was unconventional by necessity.

This is inaccurate, as evidenced by the successful conduct of phase 3 trials in the disease state, including trials of immunotherapy. The issues they ran into are surmountable. An external control arm is one solution for what they encountered, but it has several well-documented flaws that people here dismiss as technicalities.

You are completely wrong in stating that the ethics of the trial were what necessitated the ECA. The primary reason they used PFS as the endpoint was because OS was never going to be interpretable in the setting of trial crossover. By switching the primary endpoint to OS, they introduced this ambiguity. I get that you don't trust actual experts and would prefer to rely on AI, so I'm not opening the topic up for readjudication.

Suffice to say, if there were no issues, there is no reason for the application review to take this long. To my knowledge, the MHRA does not have a direct equivalent to an ODAC, so it is likely as not that we will never get public disclosure of details that the MHRA may have issue with. We'll find out soon enough, I suppose.