NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Let’s look at the language you quoted:

“The Company is in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.”

Sorry, if they were only talking to NIH, which really is not sponsoring directly with NWBO, they sponsor UCLA, or with UCLA, that language would not be relevant and would be deceptive. Such trials are not “strategic” and typically combinations involve drugs with other companies involved. Sure, a university in theory could be contracted with the company to have a researcher be the primary investigator for the trial, but they would not write it that way and I think we all know that… further, they did not say that they have a deal yet, so the desperation to insist they can’t even be negotiating strategically, is a very far way to overstate a bash. It’s not even a believable argument given the actual language. But anyone can argue anything and your argument is in such a category of argument. In theory, humans turn to stone or burst into flames from time to time too… about the same level of argumentation.

As to their PR… it’s called a “timeline”, which is fairly routine. This one is short. They have said it in other places but shorts were putting out various false deadlines and suggesting the time for applying this year had passed and given the nature of shorting in this stock and fudsters, it made sense to again clarify their immediate intention without any ambiguity.

As for applications being accepted by regulators, yes, I have argued that I thought it made sense to PR after acceptance rather than application with the fda. This PR was not about the fda.

In this case NWBO says as a part of the title to their PR, that they believe that they have completed all prerequisites to making their MAA. This suggests to me that they are in heavy consultation with MHRA. Further, NICE restarting the application simultaneously suggests to me that they likely have had heavy consultation with the MHRA possibly via their latest accelerated programs. However, I think the company sees no utility in announcing any such regulatory advantages because of past abuses by shorts, turning good news to bad new including when they got their PIM.

So, while no one can say that during the 28 day assessment period that every drug goes through in application will go through to full acceptance without finding a further requirement, given the wording of the PR, it appears that they are in heavy discussions and feel fairly confident that they have addressed all necessary prerequisites that would typically apply.

I think you again, like a few others, are looking for anything that could possibly go wrong and stating those things as a dour absolutely likely thing. We see this every day, and while timelines are typically difficult for these tiny companies in general, the company has been generally fairly accurate, compared to typical companies, in similar situations, with regard to recent applications and approvals with the MHRA, for instance with regard to commercial and other manufacturing approvals. They seem fairly comfortable with this regulator. The regulator themselves have had issues which have been publicly discussed about being short staffed or taking a little more time over the previous years post pandemic. That’s not NWBO’s issue, and I doubt it still applies in any way, but they also have Brexit and relied upon expertise at the EMA previously that they have had to scale up to address and this is a new kind of a product, so any additional issues or delays in my opinion, if nothing is incomplete, will be on the MHRA. There is nothing a company can do about that.

But yeah, one can claim all kinds of bad things will happen. There is no indication of anything of the sort at the current time, and assuming they file as expected, it will most likely be in the hands of the MHRA completely.