Replies to post #63414 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

doingmybest,

What if, as I have come to believe possible from what I know about the equipment, process and NWBO's unique advanced understanding of DC maturation, there was an "unexpected" improvement in therapeutic outcome found in those who received treatment from the closed system process in the U.S.? Now suppose the Europeans first challenged then more recently approved it's use then indicated last week that they would accept the patent when the translations for final approval are accepted. Then on top of all of this the Europeans wanted proof of approved manufacturing capacity because they are extremely confident from what they have seen, ie expanded access, and their long history of DC research, that there will be high demand due to Doctor awareness and advocacy at large German hospitals.
This is purely speculative on my part but I believe the way Cognate improved selectivity of DCs from other cells with the closed system process actually creates a more potent DC and may have been done "accidently on purpose" to create a "suspicion is not proof of guilt" improvement. Kind of like using underinflated footballs in the playoffs. The time that has passed may just be the German process with a little frown added in from the "unexpected benefit" and nod of approval with the patent grant. This may be another part of the reason why all patients seem to be living longer and are creating the type of situation you have envisioned.

[Poor Man -]

I am back to square one and believe it was caused by an IA and ensuing dialogue with regulatory bodies, which led to a question about the data, which required additional data submissions to regulatory bodies.

That's the simplest and most likely explanation.

The more elaborate theories like the "patent theory" are well thought out, but may be coincidence, and likely wouldn't elicit Linda suggesting the halt as a positive development. The IA theory just seems to make the most sense, especially with the on-going dialogue and submissions (presumably) to the FDA to update trial data.

There's still a great deal of uncertainty given how this long the halt has dragged on, but the efficacy theory also conforms nicely with positive comments from the company and comment(s) from the lead investigator about all patients living longer.

As a side bar, if there is a meeting between NWBO and VP Biden, keep in mind that Biden is not likely to be well versed in (or care about) the nuanced statistical issues regarding clinical trials. If he hears there's a significant extension in OS and the FDA is being excessively bureaucratic, he will blow his lid. There are some caveats about what happens from there, but I'm sure he would make at least a couple of phone calls.