Northwest Biotherapeutics Inc (QB) (NWBO) News

I guess when you flip long is when we should expect the price to go up, still holding that heavy arse short eh?

exwannabe,

There is nothing obvious about what has happened with FDA and NWBO other than FDA obviously interfering with the powering of the trial by allowing the treatment arm to be fully enrolled after the halt but not the SOC/placebo arm. That is a self implicating clear case of interference which must be for a positive reason for the trial outcome because nothing negative was disclosed by NWBO or FDA which would have been required to explain this action for negative reasons. There are some things that make much more sense than stating that OS change to the primary endpoint was rejected which is an exaggerated assumption.
FDA will not tell NWBO that a change of OS to a primary endpoint is being rejected until a formal review of the change in a BLA submission describing the need for the change along the exceptions pathway to adequate and well controlled studies is made. On the other hand, it was basically incumbent upon FDA, because of their interference by insistence upon crossover, reduction in powering of the trial and the orphan status of L, to work with NWBO to provide input along the way as to how they would proceed forward with determining what adequate measures might be considered regarding the blinded data they had to work with. With this in mind the SAP was most likely submitted basically with pre submission commentary that would have been sufficient along with the help from Dr Duffy with determining final presentation of same for consideration. There was no negative feedback within a 30 day period from being submitted which means it was accepted.. not approved.. but accepted as potentially approvable based on how the data is presented with conclusions drawn utilizing the actual measures chosen for a marketing submission.
No marketing submission has been made yet so the much more likely scenario vs rejection of OS as the new primary endpoint is that there was concern about the artisan method being limiting for any consideration of L as SOC for GBM, rGBM and potentially for lower grade gliomas.
FDA likely suggested that NWBO seek approval for L when they could quickly be able to provide it as standard of care for at least GBM and rGBM and have a more closed system in place to alleviate more safety concern related to the more open artisan method.
If someone in FDA had been hinting, as you suggest, that another trial would be needed ahead of a marketing application that would likely be due to big pharma influence. That influence might now be potentially traced back through discovery in the market maker trial especially since FDA intervened and could be considered suspect with regard to how the clinicaltrials.gov site was dealt with that led to what seems to be market maker interference with price discovery. I don’t think FDA would want themselves exposed like that so I doubt they went in that direction. On the other hand it would be hard to move L towards standard of care when sufficient production of product is not available due to the limitations created by artisan methodology and safety concerns from a more open process could also be raised. This is especially true when considering that Flaskworks was being worked on and big pharma could be seen as possible expansion partners during ramp up. This seems like a much more likely strategy for FDA to deal with, is something NWBO has hinted at with the concept of franchises and at least Merck and Walgreens have connections to or commented about prior to some non specified product, vaccine related cryo capacity buildout; ). Then again it could just be FDA breaking the rules by giving NWBO their decision with regard to OS being moved to the primary endpoint in the L Phase 3 trial before a formal process for determining if the exceptions process for adequate and well controlled studies was properly followed by NWBO and their efforts to create appropriate measures to determine treatment effect were fully adjudicated; ). Best wishes.

LOL IC when this drug is approved in the next few weeks what will be your crybaby response ??

Thank You Lykiri. Great additional DD.

Good to hear. I agree that we are looking at an MHRA approval and I think the wait is best explained by MHRA using COVID-19, the excuse that gives the whole year round.

I see. So your logic is that because it has not been approved thus far it will not be approved. Yeh, that makes a ton of sense.

That is the most twisted logic and argument any short has made thus far. I think you deserve a medal.

We'll let you do it since that is something you are interested in...😂

If so, any reasonable person who is a shareholder would regard such a recommendation as material to their decision to remain invested, sell or buy more shares

Agreed, but I really wasn’t saying that in regards to NWBO and I certainly don’t think that is the case.

I was just letting him know how the procedure worked so he has a clearer understanding when doing that DD.

Polska,
I, too would like to see stakes in the hearts of these corrupt, filthy rich gangsters.

RICO or not, Posner will have a lot more leverage after we are approved.

If it looks like a duck, and walks like a duck, and quacks like a duck, then it's most likely a duck,.... exit stage right

DCVAX L is most likely a duck..... I mean following in the (waddling) footsteps of the other 90% of the treatments that have been approved after appearing in the CHM meeting minutes, as you infer!!!!

Didah didah didah that's all folks!!!

gallium-68 (68Ga) gozetotide (a medicine for diagnostic use only to allow the imaging of prostate cancer). This medicine had its first CHM meeting on 4/25/24. It goes by the name Illuccix, and is owned by Telix Pharmaceuticals. It has been languishing in the process for a long time – this is the poor drug that had to wait a full year for its first meeting. Also, it is the one drug out of the 24 I looked at that publicly mentioned receiving its RFI. One single drug, out of 24. So next time someone tries to tell you it's unusual for a company not to PR updates, know that they are just making that up. And if you are one of the people here clamoring all day every day about the company's "unusual" or "suspicious" strategy regarding communications about this process, know that you are wrong, and everyone here knows you are wrong.

13 Jan 2025

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024)

Illuccix® global regulatory submissions: The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM) is expected to provide its decision on the Company’s EU marketing authorization application on 15 January 2025. In the United Kingdom (UK), the Company has responded to all queries with no substantive issues raised. The UK regulator (the Medicines and Healthcare products Regulatory Agency - MHRA) is experiencing significant administrative delays but an approval decision is expected this month. The Brazilian Health Regulatory Agency (ANVISA) is expected to provide a decision imminently after protracted administrative delays also unrelated to Telix’s marketing authorization application.
https://ir.telixpharma.com/news-releases/news-release-details/telix-exceeds-fy24-guidance-us142m-q4-revenue-0

18 July 2024
Telix is expecting to receive a regulator’s assessment report by the end of July 2024 from the UK Medicines & Healthcare Products Regulatory Agency (MHRA),

22 August 2024
The UK Medicines & Healthcare Products Regulatory Agency
(MHRA) regulator's assessment report has been received with no substantive issues raised. Decisions expected in H2 2024.

It is looming!

This is the 5th most read board on iHub. Look at Hot, above.

You posted at 3:54PM. Very close to closing, which would be busy anyway.

iHub shows a lot of statistics. Quite transparent.

RICO would have to be brought as a criminal charge. Posner is strictly Civil litigation.
It's a factor, but hard for Posner to use as leverage.

That being said, I don’t know how things work behind the curtain. Maybe if MHRA want to reject, rather than going through a CHM review, they can simply relay to the sponsor that they would recommend withdrawing/resubmitting. Who knows.


If so, any reasonable person who is a shareholder would regard such a recommendation as material to their decision to remain invested, sell or buy more shares

So looks like approval date is 1/22, Wednesday?

The first thing that comes to mind is that maybe it’s common for applications to be denied prior to the first CHM meeting, in which case they wouldn’t appear in any of the minutes. But who knows, there may be some other explanation.

I appreciate the DD and info here.

Just an fyi for you, this scenario isn’t necessarily possible.

The MHRA isn’t allowed to outright reject an application. If they recommend rejection, it must go through a CHM review first as a matter of procedure. The only way to skip CHM review is with an outright approval.

That being said, I don’t know how things work behind the curtain. Maybe if MHRA want to reject, rather than going through a CHM review, they can simply relay to the sponsor that they would recommend withdrawing/resubmitting. Who knows.

Thank You TVA! Excellent Due Diligence follow up. Well done!

Fexapotide Triflutate (the submitting company seems to have gone through some kind of bizarre corporate crisis recently which appears to have delayed their application in another jurisdiction, so that may have happened with the MRHA application as well)

July 16, 2024

Nymox Pharmaceutical Corporation (“Nymox”)

The Company's MAA to MHRA in the U.K. is in the active process of responses to questions received from MHRA. Nymox will update later in the cycle when appropriate.

Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) announced today that its MAA submission to the Danish Medicines Agency (DKMA) has run out of time and in order to continue will be required to extend the MAA application to DKMA by re-submission with a new fee required. As it currently stands the application “does not meet the conditions of the Medicines Act for issuing a marketing authorization.” Although a great number of questions were resolved by the Company, there remain further responses required that will require additional cycle time.
https://www.globenewswire.com/news-release/2024/07/16/2913880/10918/en/Nymox-Required-to-Resubmit-Application-to-DKMA.html
Nymozarfex is the brand name for fexapotide triflutate, a pro-apoptotic protein developed by Nymox Pharmaceutical Corporation for the treatment of benign prostatic hyperplasia (BPH).
SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 30TH AND FRIDAY 31ST MAY 2024
LICENSING
NEW DRUGS (not previously licensed in the United Kingdom)
The Commission considered and advised on:
• a medicine used to treat adult patients with a type of liver disease known as primary
biliary cholangitis (PBC) which can get gradually worse over time and without
treatment may eventually lead to liver failure. It can also reduce itching that is linked
to PBC.
• a medicine used to treat men with an enlarged prostate (benign prostatic
hyperplasia, BPH[)?/b]
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1722460230204

You have your view of the future and you could be right although I seriously doubt that.

As for denial, that is your problem not mine.

I'm quite comfortable with my investment in NWBO.

Thanks, but I have already tried that. No cigar.

I’m not being selective in the medicines I’m looking at; I’m just going off the medicines that appear in the CHM minutes.

The first thing that comes to mind is that maybe it’s common for applications to be denied prior to the first CHM meeting, in which case they wouldn’t appear in any of the minutes. But who knows, there may be some other explanation.

The fact remains that, whatever the reason, 90% of the medicines that appeared in the CHM minutes were approved going back over a year. And now, as of June 2024, DCVax-L has appeared in the minutes. And we are currently in the window when, based on recent trends, other medicines appearing in the minutes have been approved.

Yes getting something similar, along with the posts not being updated for hours. Really sucks..

Gaslighting strategies

I notice that Hoffy is attacking AF (who is 100% a piece of #$%^). But this tells me that we aren't going to get a decision from the MHRA for a while because they are distracting with nonsense to prevent shareholders from focusing on continued silence and dilution

I think NWBO is causing this delay, affecting everything in the world including your browser.

Blah blah blah. At the beginning of 2024, the data circulating here about the average approval time was 3 months (90 days), and now it’s 300 to 450 days. I wonder what the next number will be. What’s funny is that discovering these new numbers makes people think they’re so knowledgeable, as if they knew this data before, when in fact they’re just as clueless as everybody else last year.

I wouldn't care about those people. Believe whatever they want to believe. You do you.

Great work tunnelvisionofplenty.

Avacincaptad pegol, (which appears to have been delayed by the company for some reason – possibly because it was not approved, although when drugs aren't approved I've often seen the NICE status updated to reflect that the drug was completely withdrawn from consideration so that may not be the case here)

NICE has postponed the appraisal of avacincaptad pegol, (also known as Izelvay in Europe) to November 2025 at the request of Astellas, likely to allow the company to gather additional data and submit a more comprehensive and robust dossier. This delay appears to be linked to the withdrawal of the MAA from the EMA in October 2024 due to concerns regarding the effectiveness of the product, as well as the FDA's issuance of a Complete Response Letter (CRL) in November 2024. Izervay was previously granted FDA approval on August 4, 2023, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

NICE
17 December 2024
Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late November 2025. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
https://www.nice.org.uk/guidance/awaiting-development/gid-ta11511

EMA
Astellas Pharma Europe B.V. withdrew its application for a marketing authorisation of Izelvay, a medicine intended for the treatment of geographic atrophy caused by age-related macular degeneration (AMD).
The company withdrew the application on 24 October 2024.
The application was withdrawn after the European Medicines Agency had evaluated the information from the company and prepared questions for the company. After the Agency had assessed the company’s responses to the last round of questions, there were still some unresolved issues.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew the application because of the Agency’s concerns about the effectiveness of the medicine.
Active substance - avacincaptad pegol
https://www.ema.europa.eu/en/medicines/human/EPAR/izelvay#overview

FDA
The US Food and Drug Administration (FDA) has accepted the revised supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025. This revision was in response to the Agency's November 2024 Complete Response Letter (CRL).1

According to the company’s press release1, the application was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period. This sets the target action date for February 26, 2025.

The sNDA seeks to add positive 2-year data to the IZERVAY US Prescribing Information based on results from the GATHER2 Phase 3 clinical trial.1

The company noted1 that the impact of this matter on Astellas' financial results for the fiscal year ending March 31, 2025, is expected to be minor.

IZERVAY was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD.1
https://www.ophthalmologytimes.com/view/fda-accepts-revised-supplemental-new-drug-application-for-izervay

Still better than Newman who apparently was millions of shares but has disappeared like other select few 

Yes, sometimes. Try exiting out of the browser (X), then open a new browser instance and go to history and restore the open tabs.

It won’t hit a $1. There will again be a ton of bag holders who will be left wondering why they didn’t sell on the spike when the opportunity presented itself and got too greedy hoping to exit at a $1.

What do FUDsters do when bored? Banter FUD among themselves. 👿☠️

What delay?
I have no disagreement with your data, or this assertion. The data is not any different from 2023. But back in Spring 2024 you did not think it could even be as late as Fall.

The issue is the continued pattern of "soon" followed by "you should have expected years",

Will eagerly await your update come Spring '25 when the next gen of crickets hatch.

Is anyone having large delays (as long as 1/2 to 1 minute or longer) in response time from iHub just to simply read a post? I often am now getting messages such as "can not reach site" when I try to read a post. This message then changes to the post once iHub is ready to send.

What delay?

If the clock started on the 1/24/24 validation, and there were 60 clock-off days for an RFI, then NW's MAA is at day 295, while the MHRA-reported average clock-on days for the last 12 MAAs granted July-November is 296 days.

So there is no evidence that we are delayed any more than MHRA's general delays. https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines#full-publication-update-history

So you have data on 20 examples of MHRA decisions of which none had a negative MHRA action.

Still waiting for any example of a drug that the MHRA said no to, I guess they just never happen? Or .else ...

What happened to all those drugs approved in 2024 by the FDA/EMA that were not approved by the MHRA?

Alex, I'll take how not to run a pivotal trial for $400 dollars please. There is no way in hell this mess of a trial is approvable. Just design a proper trial and execute it..........then maybe they can submit to the FDA/EMA instead of this hail mary attempt.

It will be legendary, and leave the bagholders wonder WTF just happened after it goes back to a quarter.

Most likely its not their fault, it's the flawed submission that is causing the delay, and the silence out of linda worthless about the errors they made.

Yep show us ROI on that DD 
And lot of these are pure pumps and speculations 

I doubt it will hit $1 or 2$ a share, but if it does there will be a massive sell off and many of us will kiss this POS goodby.

The compassionate use program has been in place long enough to show its impact on patients.
How can they possibly leverage the Specials program?

Though being called compassionate access, the program is basically for patients that have a special need and therefore the drug (and formulation) they need is not worth it for any company to take through approval because there is not a sufficient market. The classic case is a formulation that changes the non active ingredients to avoid allergic reactions.

This MHRA FAQ states clearly the Specials program is NOT for drugs in the approval process .

1.6 The exemption and this guidance does not apply to other unlicensed medicinal products, for example:
...
investigational medicinal products

NWBO gets away with bending these rules by claiming what is being provided in Specials is NOT mercidencel. That makes using that data a bit difficult.

Gotta be related to lp, or making a staggering 2 cent a post. Or maybe just blissfully ignorant.

As you can see, every time a post containing due diligence is being posted, it will immediately be countered by the "lets bury it in fud" doctrine.



Thanks for your service 👍🏻

If you read CO's past post, you will see he is zero for 100 in predictions. Also claimed to be buying at much higher rates than it is now. Gotta be way underwater or full of shite.

LC,

Let’s stick with facts, logic, and common sense. Independently verifiable facts include that the MHRA awarded TWO approvals AFTER the UK Specials Program had been treating patients for years…

MHRA approved the PIP and MIA (both are relevant to the MAA), and the MHRA has continued to support the long-running UK Specials Program for DCVax-L.





“His work on brain cancer vaccines received the top presentation award by the British Neuro-Oncology Society in 2022 and promises to impact the care of patients with brain tumours worldwide.”

https://x.com/nhsenglandldn/status/1874124710285631727?s=46&t=BbaVVAHSNyBEm-BUTWiU6w

https://thejns.org/caselessons/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.xml

https://www.kcl.ac.uk/news/professor-keyoumars-ashkan-awarded-mbe-in-kings-new-years-honours

https://www.bbc.com/news/uk-england-london-66378288

The company decided to submit the the MHRA, not the FDA. Not that they had a choice. The MHRA won't give a crap about the minimal compassionate use cases given they have 331 in the actual trial. They will give a crap about no patient level data in the convoluted control arm which is probably why this is sitting without movement. An RFI to which the company hasn't responded.

All the result of the greedy CEO wanting to go for it without the expertise and $$$$ of a BP. How the f--k does she sleep at night? imo

Or if the data didn't suck and they had a valid ECA per FDA guidance, they could've just submitted to the FDA and actually made investors and themselves money.

But that was never the point. Dragging this shit on forever (well until Advent is fully funded and sold) is the point.

You are just making an excuse for the inexcusable act (for legit companies) of submitting to the MHRA without a concurrent submission to the FDA.