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Replies to post #743604 on NorthWest Biotherapeutics Inc (NWBO)
01/14/25 4:32 AM
Nice and interesting analysis, but completely irrelevant >!
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although when drugs aren't approved I've often seen the NICE status updated to reflect that the drug was completely withdrawn from consideration so that may not be the case here) and Fexapotide Triflutate (the submitting company seems to have gone through some kind of bizarre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?
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.
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.
Check out seekingalpha ...
There you'll find a pretty objective report about the current situation of NWBO from GALZUS Research.
01/14/25 11:57 PM
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