tunnelvisionofplenty
25 minutes ago
As Flipper and others pointed out, the quotes you cited are not even close to representative of what most companies are doing.
Heck, the quotes from Nymox are not even representative of what Nymox is doing. Sure, in July of 2024 they included one line in one PR in which they promised to "update later in the cycle when appropriate." In the six months since then, they have provided no additional information.
As for Telix, they are by far the exception when it comes to communication, even (as Lykiri pointed out yesterday) going so far as to claim they know they will receive approval this month. Who knows why they behave differently than (quite literally) every other company? Perhaps it's because they're Australian, a nation of outlaws (it's my birthplace so I can say that).
At any rate, there is nothing in the evidence to support statements like: "wild," "unfair," "NWBO has to play by different rules than other companies," "liar and/or moron," "lying sack of sh*t," and so on.
Believe it or not, NWBO has been consistent with the vast majority of other companies when it comes to communications around this process (if not even somewhat more communicative). And their progress through the process has been consistent with MHRA's recent performance (if not even slightly more expeditious). That is what the evidence supports.
Grey_Ghost
58 minutes ago
Outstanding Shares
01/13/2025 1,329,625,491 (+1,022,428 = 3,718,525 YTD)
01/06/2025 1,328,603,063
2024:
12/31/2024 - 1,325,906,966 (152,343,464 Full Year 2024)
01/03/2024 - 1,173,563,502
2023 Detail:
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2022:
12/21/22 - 1,058,132,006
01/22/22 - 949,180,606
2022 Detail:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170751056;
The Danish Dude
7 hours ago
Nice and interesting analysis, but completely irrelevant >!
I fed ChatGPT the following five comments regarding this analysis and it disagrees with you.
I saw these comments regarding how MHRA approves or rejects medecines at mhra meetings
1
I had a little time over the weekend to look into things a little further and found some other info that people might be interested in.
- First, I went back and took a closer look at a few of the medicines I hadn't been able to ID before. Thanks to Lykiri ID'ing Tarlatamab (I initially had it down as something else), and after I ID'd another one I hadn't been able to place before (Tabelecleucel), I have now determined that, out of 20 medicines that appeared in the CHM meeting minutes and *could* have received approval by now, 18 did receive approval. The other 2 are 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) and Fexapotide Triflutate (the submitting company seems to have gone through some kind of bizarre corporate crisisrecently which appears to have delayed their application in another jurisdiction, so that may have happened with the MRHA application as well). In short, of medicines that *could* have gotten a decision by now, 90% were approved and the remaining 10% are inconclusive (can't say for certain whether they were denied or are still pending). This leads me to believe that merely appearing in the CHM minutes is highly prejudicial toward approval.
- Second, I took a look at where approvals tend to fall during each month. Excluding IRP approvals (which have a different process), approval announcements broke down this way:
- First week of the month (days 1-7): 1 approval (5.56%)
- Second week of the month (days 8-14): 2 approvals (11.11%)
- Third week of the month (days 15-21): 5 approvals (27.78%)
- Fourth week of the month (days 22-28): 9 approvals (50.00%)
- End of the month (days 29-31): 1 approval (5.56%)
As you can see, the majority of approvals came after the third week of the month, while the vast majority (83.33%) came during the second half of the month.
- Third, I took a look at which day of the week approvals tended to fall (again excluding IRP):
- 1 approval came on Monday (5.56%)
- 3 approvals came on Tuesday (16.67%)
- 10 approvals came on Wednesday (55.56%)
- 2 approvals came on Thursday (11.11%)
- 2 approvals came on Friday (11.11%)
I think the results here speak for themselves.
It would be insane for me or anybody else to draw conclusions about the specific date of approval based on this information, since (as the data reflect), approvals can be announced at any time. However, I do think it's interesting to note that: (a) the vast majority of approvals come during the second half of the month; (b) Wednesdays are clearly the favored day for the MHRA to announce approvals; and (c) 90% of medicines that have appeared in the CHM minutes over the last year+ have been approved (with the status of the other 10% being unclear).
2
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?
3
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.
4
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 mustgo 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.
5
Indeed, who knows. Maybe medicines that the MHRA is not inclined to approve are simply not recorded in the minutes in the same manner as other medicines; that is, they do not "consider and advise on" them in the same manner. For me, the main point is that DCVax-L appears in the minutes in the same manner as a group of other medicines of which 90% have been confirmed approved.
Me:
Can you research and maybe share some light on the situation and how mhra acts during chm minutes?
ChatGPT
The Commission on Human Medicines (CHM) plays a crucial advisory role within the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Its primary function is to assess the safety, efficacy, and quality of medicinal products, providing recommendations that inform the MHRA's decisions on marketing authorizations.
CHM's Role in the Approval Process:
Assessment and Advice: The CHM evaluates comprehensive data on new medicines and advises the MHRA on their suitability for approval. This includes reviewing clinical trial results, safety profiles, and manufacturing quality.
Meeting Schedule: The CHM convenes regularly, with meeting dates scheduled throughout the year. For instance, the MHRA has published submission deadlines aligned with CHM meetings to facilitate timely assessments.
Decision Outcomes: While the CHM provides recommendations, the final decision on whether to approve or reject a medicine lies with the MHRA. If the CHM advises against approval, the MHRA typically offers the applicant an opportunity to address concerns or appeal the decision. The procedure for such reviews is outlined in the Human Medicines Regulations 2012.
Observations on Approval Trends:
High Approval Rates: Data suggests that a significant majority of medicines reviewed by the CHM receive approval. This could indicate that applications reaching the CHM have undergone rigorous preliminary evaluations, increasing their likelihood of success.
Timing of Approvals: There appears to be a pattern where approvals are more frequently announced in the latter half of the month, particularly on Wednesdays. While this trend is notable, it's essential to recognize that approvals can occur at any time, and such patterns may not be consistent across all cases.
Considerations:
Pre-CHM Evaluation: It's plausible that applications with significant deficiencies are addressed or withdrawn before reaching the CHM, contributing to the high approval rates observed in CHM-reviewed cases.
Transparency and Data Availability: Detailed information on applications that do not proceed to CHM review or are withdrawn preemptively is limited. This lack of data makes it challenging to assess the full spectrum of the MHRA's decision-making process.
In summary, the CHM serves as a pivotal component in the UK's medicinal approval process, offering expert evaluations that guide the MHRA's decisions. The high approval rates for medicines reviewed by the CHM may reflect the thorough preparatory work conducted before applications reach this stage. However, the absence of comprehensive data on applications that do not advance to CHM review limits a complete understanding of the overall approval landscape.
Then I asked ChatGPT your question:
How do you find this analysis? Irrelevant?
I find the analysis relevant and insightful, as it delves into important aspects of the MHRA's approval process and the CHM's role. Here's why it's meaningful:
Clarification of the CHM's Role:
The analysis explains that the CHM primarily advises the MHRA on the suitability of medicines for approval. This is crucial for understanding how decisions are made and the high standards for safety, efficacy, and quality.
High Approval Rates:
The observation that 90% of medicines appearing in CHM minutes receive approval highlights the significance of reaching this stage. It suggests that by the time a medicine is reviewed by the CHM, it has likely met preliminary thresholds of quality and efficacy, which aligns with regulatory practices.
Timing and Patterns in Approvals:
Identifying patterns such as approvals occurring more often in the second half of the month and on Wednesdays offers a unique insight into the administrative processes of the MHRA. While these trends may not directly affect outcomes, they are interesting to stakeholders trying to anticipate approval timelines.
Speculation on Pre-CHM Withdrawals:
The hypothesis that some medicines may not appear in the CHM minutes because they are withdrawn or rejected earlier is a valid consideration. It points to the possibility of a "filtering" mechanism that ensures only well-prepared applications reach the CHM stage.
Context for DCVax-L:
The analysis links these observations to DCVax-L, emphasizing its presence in the CHM minutes as a positive sign. This is especially relevant for investors and stakeholders following its regulatory journey.
Transparency Issues:
By highlighting the lack of data on applications that do not reach CHM review, the analysis sheds light on a potential gap in transparency, which could be an area for future improvement in MHRA communications.
What Could Be Improved?
Causality vs. Correlation:
While the data shows trends (e.g., timing of approvals), it’s important to clarify that these are correlations, not causal relationships. Approvals may coincide with the second half of the month due to unrelated administrative reasons.
Broader Context:
The analysis could benefit from a comparison with other regulatory agencies (e.g., FDA or EMA), which would provide a more global perspective on MHRA's practices.
In conclusion, the analysis is relevant, especially for those tracking DCVax-L or similar therapies. It connects regulatory procedures with real-world outcomes in a logical way while identifying areas where additional data or context could strengthen its conclusions.
When you said the following about the Seeking Alpha Galzus research (LOL) report ...
Check out seekingalpha ...
There you'll find a pretty objective report about the current situation of NWBO from GALZUS Research.
You also said: Main pro-and con-points listed
No, they were absolutely not. Galzus left out pretty much all information, that would ruin his predominantly bias against NWBO and DCVax-L approval. And when one made up for that and gave ChatGPT the "FULL PICTURE", THEN we had the main pro- and con points and THEN Galzus' hypothesis were hammered.
This post dissects in details Galzus pretty weak report and point out exactly, what he/she left out (omissions) from his "report", in order for it to corroborate his bias.
Just another hit piece, as all longs are aware of.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175530865
eagle8
7 hours ago
Someone without a name wrote this ;)
➡️MTD Timeline: More Speculation⬅️
For all of those, including myself, (im)patiently waiting for $NWBO's spoofing case Motion to Dismiss (MTD) decision, I've done a deep dive into Magistrate Judge Stein's Report and Recommendation (R&R) timelines.
First, I'll give a quick summary of the data. Then I'll go through the data in detail. Finally, I'll offer some thoughts.
Summary Data
✅Days R&R was released:
Monday (2)
Wednesday (1)
Thursday (1)
Friday (4)
✅Average time from last briefing to R&R release:
~5 months
The Data
✅The Cases
Northwest Biotherapeutics, Inc v. Canaccord Genuity LLC, 1:22-cv-10185, (S.D.N.Y.)
R&R: TBD
Final Briefing: June 14th, 2024 with 12-6-24 supplemental filing
Castillo v. Isakov, 1:22-cv-06888, (S.D.N.Y.)
R&R: 12-27-2024 (Friday)
Final Briefing: 4-17-2024 but supplemental submission was allowed on 12-19-2024
Total time: ~8.5 months
Johnson v. UMG Recording, Inc., 1:23-cv-03021, (S.D.N.Y.)
R&R: 12-6-24 (Friday)
Final Briefing: July 29, 2024
Total time: 4+ months
Certain Underwriters at LLoyds, London v. Dryades YMCA, 1:24-cv-06103, (S.D.N.Y.)
R&R: 11-21-24 (Thursday)
Final Briefing: 10-18-24
Total time: ~1 month
Dukuray v. Experian Information Solutions, 1:23-cv-09043, (S.D.N.Y.)
R&R: 7-26-24 (Friday)
Final Briefing: 2-7-24
Total time: ~5.5 months
Mathura v. Social Security Administration, 1:23-cv-04886, (S.D.N.Y.)
R&R: 6-26-24 (Wednesday)
Final Briefing: 1-17-2024
Total time: 5+ months
Ortiz v. Consolidated Edison Company of New York, Inc., 1:22-cv-08957, (S.D.N.Y.)
R&R: 6-7-24 (Friday)
Final Briefing: 9-18-23 with 12-15-23 sur-reply filed
Total Time: 8+ months
Doe v. The Federal Republic of Germany, 1:23-cv-06395, (S.D.N.Y.)
R&R: 4-15-24 (Monday)
Final briefing: strange one, don’t have a final briefing date similar to others
R. v. United Healthcare Insurance Company, 1:23-cv-04748, (S.D.N.Y.)
R&R: 11-20-23 (Monday)
Final briefing: 9-12-23
Timeline: 2+ months
Thoughts
I was hoping for a MTD decision in '24, but it appears Magistrate Judge Stein was working on the Castillo case where he released a R&R on 12-27-24.
There were two outliers which took 8+ months. In Castillo the Court was dealing with Motions for Extension of Time. In Ortiz the case was stayed for a pending Supreme Court decision. I don't think $NWBO can expect to wait 8+ months because these were cases that involved unique delays, none of which Northwest has experienced. Northwest now appears to be the longest pending R&R that didn't have some unusual delay built in, i.e. we're due.
NWBO is at ~7 months since the fully briefed R&R. It would seem our decision will drop any day now. The most likely day is Friday, but it does appear Magistrate Judge Stein will release R&Rs on other days of the week.
Ortiz was pending for longer than Northwest and we recently saw the R&R released on 12-27-24. I believe/hope $NWBO is the next R&R decision that will be handed down by Magistrate Judge Stein. It's been just over 2 weeks since the Ortiz decision came down, with New Years in the middle of there. Lets hope the Northwest R&R is now front and center on Magistrate Judge Stein's desk!
biosectinvestor
7 hours ago
My understanding, and of course none of us can see behind the curtain here...
The MHRA is a collaborative regulator rather than one that seeks to be unnecessarily punitive. That is pretty much the style for the best regulators. So I agree with you on that point.
If an application has merit and the MHRA sees potential for approval, it would be reasonable to expect communication with an applicant and that might lead to some further clarifications and resubmission. They do not lean toward an outright rejection. That kind of advice can be seen as a positive signal, as it suggests the regulator is willing to work with the sponsor to achieve an approval. Of course, none of us know what is going on, and this is purely speculative, but my view is generally the regulators see themselves, to a large degree, as collaborating with researchers to get good treatments to patients and to the market, not to punish anyone with outright rejection, if a company has a fundamentally good application that the regulator believes will, if approved ultimately, benefit patients. Basically, it's a back and forth for treatments with promise.
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