Replies to post #629398 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Let me give you a little more background.

Linda Powers, December 30, 2022.

Some years ago, some of you may remember, we had hoped to embark upon combo trials years ago, and we actually have reached conceptual agreement with several other parties, and we announced this to do -- to proceed with combo trials.

Unfortunately, from a resource standpoint just couldn't do it from a resource standpoint, and we had to just stay focused on getting our lead program to the finish line, right? But now that the Phase III trial is done and as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again [indiscernible] about the past, we will be looking for the terms to be favorable for Northwest and its shareholders.

We have actually -- we actually walked away from a combo trial that we could have proceeded with before. The (historic) terms were quite unfavorable with us supposed to supply everything and receive very little. So we're not going to do that. So anyway, that's our perspective on combo trials

Those hoped for combos were with CI makers.

Now, with those things in mind, let’s go to the recent Powers 10q (seven months after the above annual shareholders meeting).

The Company is in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments. August 9, 2023

[XMaster2023]

OJ, In LP the longs place our full trust.

[The Danish Dude]

but MHRA, on close inspection, decides the application is incomplete

There's no way NWBO after 10 years of tight cooperation with MHRA, from first PIM designated medicine, to a decade of compassionate use, to MIA approval of the most advanced and licensed cell and gene CDMO explicitly for DCVax-L, to PIP plan approval to british politicians recommending and urging MHRA for approval, that NWBO are reduced to amateurs that suddenly misses out of elementaries and gets an "extended sentence".

NWBO have been reaching huge milestones and after having walked the extra mile of building a long tail of yearlong survivors LP won't trip amateurish on the goal line as well as MHRA and the UK have extreme incentives for getting DCVax-L approved.

One can just look at regulations, rules, funding and processes that MHRA have been taken steps to getting secured during only a 100 days window, that specifically addresses cancer vaccines of which no one but NWBO have one ready in said period of two years of which extra funding of £10 million will be spent.

There's not a rats chance in hell DCVax-L will not be approved swiftly and in first attempt.

But ... lets just wait and see.

[antihama]

OncoJock, you're not doing your job very well if you don't see biotechs PR submission of MA.

Also, FWIW, in my day job of writing about the latest and greatest cancer medicines, it's highly unusual for a company to issue a press release announcing its intention to file a regulatory submission. In my experience, it's far more normal for a company to announce that an application has been accepted by a regulatory authority. Here's why: Just because NW Bio submits the application, doesn't mean the MHRA accepts it. The MHRA may require all kinds of additional info from NW Bio before it deems the application to have been submitted in a full and satisfactory manner. This may easily take a great deal of extra time, which of course no one is including in their timelines for a possible regulatory decision.

Every biotech that I spot checked PR'd submission of their BLA/MAA. Are there small public biotechs that just PR acceptance of Marketing Application? Maybe, but I haven't seen it in my spot checks. I noted other companies PRing the beginning of the Rolling Review process and the submission of the RR process in post 603724 and 606391, and earlier posts where they PR'd submission of the application. Another poster noted another submission PR in post 606027. Regarding, NWBOs PR announcing its intention to file a regulatory submission, many were hoping we'd get a submittal PR per the MHRA submittal timeline (~Aug 28th). So I think the Aug 29th PR was the perfect salve for what ailed longs.

[hoffmann6383]

oncojack, when you write slides for other doctors to present you always provide financial disclosures. Are you able to provide your own and let us know who is footing your bill to write negatively about 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.

[dstock07734]

OJ,

Just like what you did after Dr. Bosch's presentation in June, you are here again trying to spread doubt or rumor on the management.
I have no patience to rebut you line by line. It is the firm belief of all the true longs here that in one month, amazing things are going to happen.

[HappyLibrarian]

One advantage of NWBO taking forever to apply (at a measurable cost in lives and dollars) is that there is virtually zero risk of an incomplete application issue of the you kind suggest is possible.

There is a greater risk that a hurricane will blow away the office in Bethesda and the application is lost than there is if their taking all this time (3 years from DL) and doing an incomplete application. The former is highly implausible but I presented it because that’s just the point.

[jon_k84]

The scenarios you describe are technically possible, but highly unlikely.

-It makes zero sense for NWBO to issue a PR about intentions to submit MAA if they know the application is incomplete. Among other things, they'd be opening themselves up for litigation. Is it possible they submit and are delayed... of course (but also unlikely)... but knowingly submit an incomplete application? No way.

-While we can't say with 100% certainty the exact entity involved in the combo trials discussion, I am almost certain it involves BP. You need both significant funding and permission from the patent holder. No way either those happen without BP.