NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Looking today at LessIsMore link to the UK’s gov site noting common issues: Validation cited [url]
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174398340&txt2find=receipt[/url][tag]here[/tag] where he states:

If the application is valid then the assessment period will begin. This starts from the date of receipt of the valid application. If the application is not valid, then the person making the application will be told of the deficiencies

I also wanted to note the exact verbiage from that section here which LIM linked and commented on,

Your submission will be validated on receipt and an acknowledgement letter will be sent to the person submitting the application. This is the person named in section C of the CTA application form (Annex 1) and Declaration of the End of Trial form (Annex 3) or section D of the Substantial Amendment Notification Form (Annex 2). If the application is valid then the assessment period will begin. This starts from the date of receipt of the valid application.

And going back to Flipper’s post re: his conversation with ChatGPT re: the whole idea of a “receipt” noted here and which he posted,

I apologize for any confusion caused. In the context of a 150-day MAA (Marketing Authorization Application) process for evaluation, the timeline usually starts from the date of receipt of a valid MAA by the regulatory authority. The clock starts ticking on day 1 from the receipt of the valid submission. ??The confirmation of validity, which confirms that the application is complete and meets the necessary requirements, may take some time after the initial receipt. However, this confirmation does not typically reset the clock or delay the evaluation process. It serves as an acknowledgment that the application has successfully passed the initial validation and can proceed to the next stages of evaluation. ??Therefore, in most cases, the evaluation timeline for the MAA starts from the receipt of the valid application, regardless of the time it takes to receive the confirmation of validity. The 150-day evaluation period would be calculated from the date of receipt of the valid MAA.

...All of this talk of “receipts” reminded of my post dated 1/03 where I first noted the “receipt” of Northwest's application, and my “understanding” of the matter (which seemed very clear at the time), that I’ve cited below and linked here:

sentiment_stocks

Re: flipper44 post# 661240
Wednesday, January 03, 2024 7:00:36 PM
Post# 661260 of 690658
It’s my understanding that when the DCVax-L MHRA application was filed (back on December 21), this was done after the company had received confirmation (a simple receipt from the MHRA) that the application had indeed been received. It’s just a receipt… it’s the “validation” of which you note…. something like what the SEC provides when a filing is made on Edgar.

The company then announced their filing of the MAA with the MHRA, received their "validation" as you call it (basically a receipt), and that’s the end of it.

After that, the old adage “silence is golden” kicks in and all discourse between Northwest and the regulator is kept private. I believe that the company takes the position that the regulators do not look favorably on any type of public announcements regarding the status of the MAA with the MHRA until such time as something material happens (and that wouldn’t be that the MHRA is in receipt of the MAA).

Therefore, looking for any other type of “validation” regarding the MAA and its application status with the MHRA, and I mean this nicely, is a complete waste of our time because we’ve already been given it. They would never have released the December 21, 2023 PR if they’d not received confirmation that the MHRA had received it. End of story.

So circling back to the MHRA’s guidance on the subject (although it does seem rather nuanced and a bit all over the place, oftentimes when we look back at something later after becoming in possession of what are the actual facts of the matter (from the 5/10/24’s Q cited here

MAA Application. As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.

As is typical, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company will announce the results when the regulatory review and decision - making about the MAA is complete.

…we can perhaps take those facts and try to deduce what they might mean with regards to future events (which is what all of us are obviously trying to do).

To me, the MHRA text reads that the 150 day clock begins on the day when a valid application is submitted, and a valid application was submitted by Northwest to the MHRA on 12/20/23, and the receipt for that valid application was received at that time, as I’d noted back in the beginning of January 2024. Now it may have taken until 1/24/24 for the company to receive the notification that the application was, indeed, valid, it doesn’t change the fact that the application was also actually valid on 12/20/24. It just took a bit of time for MHRA to affirm this (which it could be argued, is part of the assessment), and then confirm this fact with the company.

Now returning to the 150 day application requested by Northwest of the MHRA, with an explanation of it linked here:

The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed within 80 days after clock start. Concerns arising from the initial assessment will be raised with the applicant as a letter requesting further information (RFI).

So there are an initial 80 days for the first assessment phase to be completed (perhaps earlier, or perhaps later, depending on the MHRA meeting their own imposed timeline), and one might logically argue that the process of validating the application would also fall into that first 80 day assessment timeline.

Now if the first 80 days began as of 12/20/24, then 80 calendar days later would be 11.43 weeks… putting us at March 6, 2024 (11 weeks) and 3 days later (.43), or March 9, 2024. And in keeping with that 80 calendar day timeline, I do find it interesting that March 7, 2024 is when Northwest notes that they received their “notification that the validation was confirmed.”

It's possible this could just be a coincidence, but because the time is so very close to 80 days from the original submission of the "valid" application, it's also entirely possible that the March 7, 2024 confirmation of validation could also mark the MHRA conclusion of the 80 day phase 1 of the 150 day assessment (which included the validation). I mean, they company had already received confirmation of validation on January 24, 2024... so why was there the second confirmation, pretty much 80 days after the company had received their "receipt" for the application?

If then, the first 80 days of the process were completed on March 7, that would also mean that the company did not receive an RFI request (which if they had, one could argue, would indicate the application did not pass the validation process and the MHRA required more information). And because the 1st 2024 Q filing indicates that the company has not had to amend or add to their application, the receipt of which they received 12/20/24 when they first submitted the application that passed validation, this is fact argues further that there was no RFI request.

So if this deduction that the 80 day part of the process has passed is correct (and to be clear, this is obviously not a fact, but is simply based on taking the facts that we are in possession of, and trying to infer what those facts might lead to in the future), then that would imply that the next 70 days of the application process began on or about March 7 or 9, 2024.

If that is the case, then 70 calendar days later (I’m going with 5/09) would be May 18. Now I don’t mean to get anyone particularly excited by this date, as it represents
1) simply my own musings, and
2) even if correct, the MHRA may very well take longer than 150 days for the approval assessment process, as 150 days is just a goal, on the MHRA's part.

Additionally, the Q indicated under the “Preparations for Regulatory Inspections” that the MAA inspections have not occurred as of the first quarter, and the sentence at the end of that statement implies that inspections STILL had not taken place as of 5/10/24. See entire section quoted below:

Preparations for Regulatory Inspections. As anticipated in the Company’s prior reports, preparations for regulatory inspections associated with the MAA have continued to be a major focus of the Company’s activities this year to date. The Company has continued working intensively with teams of expert consultants in both the U.S. and U.K. on these preparations, and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies. It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.

So, even if it is correct that the first 80 days have passed and there was no RFI issued, I’d think wrapping up the 150 day process by 5/18 is still too soon. However, given the facts, it still seems very possible that the first 80 days of the assessment process has passed, and that no RFI was issued, IMO, and that the MHRA is trying to stick as close as possible to their 150 day clock.

Again, these are just my thoughts.