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:

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



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,



...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:


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



…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:



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:



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.

“And another one gone…” it would seem another one of the resident bears have gotten the boot… what is going on here? Will this “female power broker” return as herself (as did nemesis) or in another guise?

https://investorshub.advfn.com/boards/profile.aspx?user=840664

As I stated in the post you responded to, Linda Liau told me herself that the product is the same.

Just wondering… is it possible NICE marked your folder as “NUTS”?

If Northwest was not a trial sponsor, then it’s unlikely they could use the DCVax-L name. That’s certainly the case wth the other trial at UCLA using Keytruda, poly ICLC, and an autologous DC vaccine.

Still, please note, Linda Liau told me to my face at an event where I had a chance to speak with her for about 5 minutes that their autologous DC vaccine is exactly DCVax-L. So the question that remains is if you believe me on that last point, or instead, do you believe LL?

Below is a post that I wrote back when the Nature article was pre-released re: the results.

I'm linking it again below as it's very helpful, IMO, as a synopsis of the results of the GBM patients.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172833579&txt2find=methylated

To me, the first stat to note is that the GBM patient who lived the longest in this trial was a methylated patient on PLACEBO only - so JUST DCVax-L.

Next, out of the 5 GBM patients on Poly ICLC, the mOS was 28.6 months - and that median was an UNMETHYLATED GBM patient.

So, IMO, when you add in the Poly ICLC, it looks like the unmethylated GBM patients now have a legitimate shot at turning unmethylated GBM into, minimally, at least a chronic disease that can be treated over and over when the tumor returns.

When you look at the section of the just-released Nature article entitled:

it describes how the DCs used in this UCLA trial were established:


When you click on the link in the article for the No. 6. footnote I've bolded and colored above, Liau's JAMA article comes up.


I think that suggests that the two methods used (in this trial described in Nature, and in the DCVax-L 3 P3 trial) are the same?

Hmm… that is odd, if I’m not accidentally on ignore. I don’t ignore anyone (as a mod, I probably shouldn’t), so I don’t know how the ignore function works.

I think both Bigger and thermo are invested as private investors, and not as fund managers.

But they would likely still have to file a 13g if they owned 5% or more of the company individually, so they likely do not own that much at this time. I think 5% would be around 60 million shares or so? I think thermo had somewhere near 90 million with stock and warrants as of several years ago, but I don’t think warrant ownership would trigger a 13g filing.

From 2/06/24 NWBO PR:

And as you point out, from today's 8K - 5/02/24


PR to be read that the funds are to be used for these four items:
1. the Company’s ongoing business operations
2. beginning initial construction works for the first grade C lab in the Company’s Sawston, UK facility
3. ordering certain initial long lead-time equipment for the first grade C
4. facility preparations for delivery of the initial GMP units of the Flaskworks system.

Now what the word "several" means to Northwest is unknown, as some of us have seen the word mean as much as 7 or more months. Still, if we take it to mean what most people think the word means (about 3 or 4), then the company may indeed be close to receiving those GMP-grade Flaskworks units.

My NWBO buddy Richard just posted a tweet thread that merits some DD consideration.

All this talk about buildout of cleanrooms and $NWBO’s capacity to manufacture $DCVax one thing that is being overlooked is the connection between the company and EW Helathcare. EWH, a private investor in healthcare companies, was part of the group that provided financing

— Richard Fairgrieve (@RichFairgrieve) May 1, 2024

lol! :)

At least we can say "bye bye" to Nemesis. He's been kicked off I-hub.

https://investorshub.advfn.com/boards/profilea.aspx?user=845347

If you don't think DCVax-L will be approved, what good will the millions of options be to management that they've awarded themselves?

I understand you think this is all about building out Advent, which currently consists of personnel and a lease on the Sawston building (and NWBO shares for achieved milestones), and given that, I'm curious why you would bother bringing up what I'm sure you must consider those useless options?

And there are 80 or more of them across the nation and in the UK, Canada, and Germany who were directly involved in the trial. Pretty sure they're following the regulatory process as it moves forward, too.

Well that's not good... for Car-T (or patients).

Is it any surprise, though, that the Car-T developers "stress that the benefits of their cancer therapies still outweigh the risks."?

Norisk... I don't think you're correct on German Colonel being short. That's my personal opinion, but likely the opinion of a good many others here.

Below is a post that I'd made back in Nov 2018 re: what had happened to me when I tried to look into obtaining the physical certificates to some of my shares in one of my Schwab accounts. It may be helpful to look over for anyone considering taking that type of action.

I was going to mention that I thought making a move like transferring shares from your brokerage to ComputerShare would probably make the shares untouchable and ensure that they are not being used for shorting - although I'm not sure if Computer Share still houses their share with the DTC (I honestly don't know and perhaps someone else knows the answer to that straight away, although I'm sure a little research would indicate whether this is the case or not). If they're still in the DTC, then that could potentially still be a problem, if you believe there is a large naked share position.

But again, if your shares are in a Roth, then unless you can transfer the entire Roth account to Computer Share, I don't see how you can move them out of the Roth and hold on to the ability to benefit from the potential tax advantages should the share price rise.

Fidelity will likely take them. They will take NWBO shares transferred from Computer Share.

Again, though, this is NOT an action I’d recommend for anyone using a Roth account. And I think quite a few of us are using those.

Schwab doesn’t allow the transfer in of any OTC stocks. Schwab will allow you to buy OTC stocks with them; but when you do, they place warnings of those buys. Perhaps they feel that because they’ve warned you, you do so at your own peril.

Of course if you have your shares in a physical form, you will securely own those shares. But because the market no longer buys and sells shares in that form (paper certificates), it’s my belief that you’ll have to give them back to one of these companies (Schwab, Fidelity) in order to sell any of them, in the event that you might want to. And I don’t think Schwab will take them back, as an OTC stock.

To continue on this thought, please let us know if this works out differently for you.

One area where this would likely present a problem is when these shares are kept in a Roth account, as I don’t believe you can just remove those shares, and then put them back.

I don’t believe these entities can present you with paper certificates. I think they can transfer them to Computer Share, who can them give them to you in a physical form. At that time, then, they are no longer available in the market to be bought or sold, which is fine, I suppose, if that is your intent. Then if you wish to put these shares back into the market, you will likely have trouble doing so at Schwab as they currently do not accept transfers of NWBO into their accounts. You can purchase NWBO through them, but you can’t transfer shares in. Perhaps they will allow those back that you’d originally bought with Schwab, but that can be a month(s) long process. Fidelity will take them, though.

That’s my understanding of the process, via my own past experience with Schwab.

A wood chuck would chuck all the wood he could chuck if a wood chuck could chuck wood.
:)

Regulators do not like it when companies speak to the status of their marketing applications publicly. It’s a good thing you are usually careful to remember that these careless musings of your’s are simply your own opinions.

Well I, for one, think your post offers a very good take on the current situation.. so thank you! :)

I have no idea. :)

Not seeing anything in there about "working" or "business" days... just plain ol' days...which was the subject of the post your responded to.

Good article on Bamboo Lounge re: Northwest. Asks with all the positive and upbeat events, it's hard to see how the share price is so low.

True Grit vs. True Grift link

From my quote you cited… the word “attempting” suggests only that Northwest would possibly be trying to get the eden system approved in time with an approval. Your take on my words seems to imply that I was suggesting Northwest was somehow trying to hold back on their submission of their MAA to line it up with an eden approval. That is certainly not what I meant, and for you or others who might have thought that this was what I was suggesting, it is not the message I intended to impart.

I don’t believe I ever wrote anything like that… all I’d indicated (or intended to communicate) in my post to bear trap was that with how long this entire application process has taken, and with some of her call outs in the recent Flaskworks PR, the eden system could be ready to implement very close to an MHRA MAA approval. Nothing more.

Um, okay, that makes no sense.

Fingers crossed, that’s how it works. :)

The wording of the Flaskworks PR leads me think they are attempting to time it “upon approval”, with the set backs in the timeline making that an easier objective…, but I most certainly could be wrong.

Tbh… I’ve often wondered if some in the FDA recommended the company apply first with MHRA. An approval first with one of the world’s toughest regulators, the UK, would help give cover in the US should BP try to thwart an approval application here in the USA.

All my opinion.

I honestly don’t think so… there was No mention of it at the time. No one was thinking that DCVax was causing psPD to my recollection, back in 2015 (except possibly UCLA, IMO).

Considering what you, and I'm sure others, cite, I have some newish thoughts on the subject.

I think that the FDA may have initially halted the trial (in August 2015) at the prompting of the DMC (data monitoring committee), whom I believe had ulterior motives, given that we later determined that the head of the DMC was also on an SAB for a Swedish company working on a competing solid tumor dendritic cell vaccine, and that his brother was on the board. Please note, after this was brought out on this board (by me), both of these positions were suddenly removed from the website of the competing company. But, it's very possible, then, that when the FDA looked more closely at the unblinded data of the trial (which I believe they would have access to, while the company remained COMPLETELY AND UTTERLY blinded), they first would have seen control patients that were eventing later than the treatment arm because the treatment arm was showing false progression - pseudo progression / psPD - due to DCVax-l that couldn't be measured correctly due to the antiquated progression determination criteria). But at the same time, they would have also (likely) seen that progression in the treatment patients was also disappearing with time. The FDA may have also seen from the data that some of the control arm patients that were crossing over were also demonstrating psPD after crossing over, that later went away. Finally, as Linda Liau had indicated in October 2015 in a videotaped presentation, all of these patients were living longer (impressively longer, IMO, otherwise, why say it then?). All of these data points would have indicated to the FDA that the trial had issues in both arms, but the safety profile was such that all patients could continue treatment. And there is the interesting fact that the treatment arm was fully enrolled, and the control arm was what, 16 patients short?

Now... as you and others have pointed out, if what I've laid out in the previous paragraph was indeed the case, the FDA would not have been able to share any of these reasons with Northwest as it would have compromised the trial and the integrity of the data moving forward.

It also could have resulted with Northwest privately feeling that the FDA may have also not been operating with honest intent, given that it would seem that the DMC certainly wasn't. Again, if this were the case, I don't think the FDA could share with Northwest their exact reasons for halting the trial. And when Northwest indicated in a public PR (I think that was in Feb 2017 or 18? - I can't remember exactly when) that they would no longer be enrolling the trial and had decided to move forward with the data they had, the FDA lifted the halt within a week or so later. Now those who aren't invested but post here 24/7 will have you believe that the reason for the lift was because NWBio indicated that they would no longer pick up enrollment in the trial. I'd argue, then, why bother lifting the halt ... just leave it in place. But lifting it does telegraph something... IMO... that the reason for the halt was not a bad one, and instead, as you, DocLogic and others often contend, rather an indication of DCVax-L efficacy, meaning... the vaccine works.

Anyhow, thought I'd post my thoughts on this, inspired by your post. :)

Thanks, beartrap, for bringing some of the facts from the recent Flaskworks PR back to our attention.

Yes, this quote definitely states they are making multiple units. I also liked the later part of that sentence I’ve highlighted in bold, as I read it as them being fairly close in the process to being able to use these Flaskworks machines to make DCVax-L upon an MAA approval… and that will likely be very helpful in garnering NICE financial support.

I don’t really know exactly what an “engineering run” is, so I googled it and found this,



I know we have quite a few engineer types here so perhaps they will weigh in.

:)

What I’m curious to know is how NICE and the MHRA would react to you coming onto an investment board for Northwest Bio’s stock and discouraging people from investing in it, while at the same time (or rather at a slightly earlier time), you went before the regulators to present why you think the MHRA should not approve DCVax-L based on your individual experience (which, to be clear, did not involve you even having ever received the treatment).

One might suggest that it looks like you’ve taking a financial position in the stock, and trying to influence its share price with your actions. I wonder if the MHRA and NICE would read your actions as such?