Replies to post #789349 on NorthWest Biotherapeutics Inc (NWBO)

[AllSheWrote]

As a prudent investor have you not considered the possibility that MHRA has asked NWBIO to provide patient-level data for the ECAs, a request with which NWBIO is unable to comply? As a prudent investor, have you not considered that this is, in fact, the most likely scenario? As a prudent investor, are you not at least somewhat concerned that company management has elected to keep shareholders in the dark about pretty much darn near everything since, oh, about 2015? As you weigh your investment, would you not consider this a very bad indicator?

And speaking of bad indicators, since this trial's inception over 15 years ago, the company published its intent to complete the trial and submit results to the FDA. That sequence of events was discussed on this message board for many years and was assumed to be a given. It was accepted that that is what would happen, and the company even stated this very clearly itself. And yet, in the end they did not submit results to the FDA, the regulator of the world's largest and most lucrative health care market. They instead submitted results to the MHRA, the regulator of the relatively tiny UK health care market. As a prudent investor, would you not consider this decision a very, very bad indicator?

As a prudent investor, why are you still holding this $0.25 stock that, at this point, has zero chance of generating any significant revenue for many years down the road even if by some miracle it does obtain MHRA approval?

[brooktrail1933]

I think the way they phrased it was deliberate.

[hyperopia]

the point of that timeline exercise was to see approximately how far the application could go without being considered "backlogged" on the part of the MHRA or Northwest.

I personally think (as you laid out) according to MHRA’s National Assessment timeline, they are nearing the outer limits of being considered backlogged. However, a view of the MHRA’s Performance Metrics Assessment over most of this period, shows this time period is about average:

Performance Metrics Assessment of New Marketing Authorisation Applications and Variations (January 2023 - February 2025)

As far as the Advent acquisition PR, I think almost everyone noticed that sentence, which certainly implies confidence. Whether it was intentional, or a “slip” we’ll probably never know, but we do know that lawyers are usually very careful with their language, so my take is that it was intentional.

I’ve always thought that the application would be approved, and thought it possible that it could receive priority review. My worst-case scenario was that the application would be delayed because there were deficiencies that needed to be addressed. I don’t think the assessment process is adversarial (as some here want everyone to believe), and I believe the MHRA wants to assist small companies that have developed innovative treatments, (particularly for Glioblastoma) to get them through the approval process, so they can make them available to their citizens.

And BTW - I also disagree with AI's assessment (but I’m not a fan of AI being used this way).
It seems clear to me that “potential” is describing “acceleration” that immediately follows it.