Replies to post #761172 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Do they still have any plan to submit evidence to NICE?

[FeMike]

That is where you and I disagree. This signaling is nonsense because it really is not in the hands of NWBO. I mean NWBO can do dumb things such as submitting a PIP redesign to the MHRA in the middle of the MHRA's decision timeline risking an MHRA pause or other stupid things to slow the decision timeline down, but NWBO does NOT know when the decision is made and therefore the suggestion of signaling is silly.

But you still can't give me any solid reasons why NWBO would include that in the 10K knowing full well it would hurt the share price.

NWBO has never, to my knowledge, commented on their ASCO presence in their financial reporting. Why start now? They could have easily left that information out and I guarantee the market doesn't react as poorly to the K as it did.

Didn't they pull their abstract last year as well? I want to say they had a placeholder and pulled out, didn't comment on it then. They still attended the conference, but still.

Honestly, had they pulled out without telling anyone, the pumping that would have gone on around it probably would have been off the charts. Speculation would have run rampant about what pulling out meant. There would have been some FUD around it as well, no doubt, but the interwebs would have been buzzing the same way they are buzzing now about the Stuttgart suspension. "Must mean news coming. Must mean approval done. Must mean buyout/acquisition. etc etc".

But no, now the only thing people think is what NWBO actually said, which is that they aren't attending ASCO in June so that they can continue working on the MAA. The quote:

The Company continued working with teams of specialized consultants on the MAA process, including onsite inspections in the U.K. and U.S., and ongoing production of documents and information before, during and after the inspections. The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year (in June) in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible.

So I agree with you, and that quote does not necessarily mean they plan to still be interacting with the MHRA, and could indeed mean they are busy with ASCO prep now and don't want to be burdened with it (I doubt it, they weren't doing anything at ASCO they haven't done in years past, but I concede it could be that). But even so, the way it more than easily reads is that ASCO is in June. They don't want to do ASCO because they want to stay focused on interactions with the MHRA. They think they'll still be interacting with MHRA when ASCO is scheduled.

It's not truth that matters, it is perception. So either NWBO is AWFUL at perception (very possible) and don't think the decision will extend out to ASCO they just didn't realize how stupid it would be to put a phrase like that in the 10K, or they understand what the perception would be and it is exactly what they meant and the reason the put it in there. There's really no middle ground here. My inclination is that they meant what they said (they usually do, oddly enough). I don't discount the other theory, that they just gaffed it up big time, and approval could still come any day.

Either way, my point stands, it's not great to have that in the 10K unnecessarily. And I disagree with you that NWBO doesn't have a much better idea of when this could happen than retail shareholders. They may not know exactly, but I guarantee they've got a pretty strong idea of the general timeframe (days, weeks, months, etc).

[dennisdave]

From ChatGTP

Yes, the MHRA has the authority to pause or delay the review of a Marketing Authorization Application (MAA) if a company submits a request to modify an already agreed Paediatric Investigation Plan (PIP), especially when the proposed modifications are substantial and impact key elements of the original plan.?

According to MHRA guidance, modifications to an agreed PIP are necessary when key elements become unworkable or inappropriate. If such modifications are proposed, the MHRA may require a full assessment to align the non-compliant key elements of the opinion with those of the completed study report. This process can lead to a pause in the MAA review until the modified PIP is assessed and agreed upon.?

While specific instances of the MHRA pausing an MAA due to PIP modifications are not publicly detailed, the regulatory framework allows for such actions to ensure that the pediatric development plan aligns with the overall assessment of the medicinal product.?

For the DCVax-L MAA, if Northwest Biotherapeutics has submitted a substantial modification to their agreed PIP, the MHRA may choose to pause the MAA review process until the new PIP is reviewed and agreed upon. This ensures that the pediatric development plan is appropriately integrated into the overall benefit-risk assessment of the product.?

It's important to note that the MHRA's decision to pause an MAA review in such circumstances is discretionary and depends on the nature and extent of the proposed PIP modifications

sources: https://www.gov.uk/government/publications/format-and-content-of-applications-for-agreement-or-modification-of-a-paediatric-investigation-plan/format-and-content-of-paediatric-investigation-plans-and-related-applications-in-the-united-kingdom-uk--2?utm_source=chatgpt.com

If the MHRA pauses or delays the review of NWBO’s Marketing Authorization Application (MAA) due to an issue with the Paediatric Investigation Plan (PIP) — such as requiring a substantial amendment before proceeding — that would almost certainly qualify as a material event under SEC disclosure rules.

[FeMike]

Another interesting conversation I had with Dennisdave last month:

In response to my claim that after conversing with NWBO (in March), my feeling is that they don't think approval will be 'imminent' but really they don't have a great idea of when to expect approval - dennisdave March 20:

That is not accurate at all. Of course they have a clue since they know exactly where they are in the MHRA process and can then from there estimate (much better than any of us outsiders can) how long the rest of the process will take based on MHRA history. If it were to be true (which I don't believe) that they are in extra RFI time then that could indicate the MHRA isn't convinced (which again I don't believe at all to be the case)

In response to my claim NWBO used the 10K to signal that approval decision may not come until June, dennisdave yesterday:

That is where you and I disagree. This signaling is nonsense because it really is not in the hands of NWBO....NWBO does NOT know when the decision is made and therefore the suggestion of signaling is silly.

Huh...interesting, indeed.