| Followers | 45 |
| Posts | 129 |
| Boards Moderated | 0 |
| Alias Born | 03/02/2021 |
Monday, January 13, 2025 2:50:12 PM
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although when drugs aren't approved I've often seen the NICE status updated to reflect that the drug was completely withdrawn from consideration so that may not be the case here) and Fexapotide Triflutate (the submitting company seems to have gone through some kind of bizarre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 crisis recently 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).
- 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 crisis recently 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).
Recent NWBO News
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • InvestorsHub NewsWire • 05/11/2026 01:00:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • GlobeNewswire Inc. • 05/11/2026 12:30:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:38:00 PM
- Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins As Strategic Adviser To Advance Dendritic Cell Cancer Vaccine Platform • PR Newswire (US) • 04/30/2026 04:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Northwest Biotherapeutics Announces Establishment Of the Company's Own Dedicated Leukapheresis Clinic • PR Newswire (US) • 04/21/2026 01:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 04/21/2026 04:15:08 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 04/16/2026 09:25:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/07/2026 04:30:50 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/31/2026 09:04:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/15/2026 10:06:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2026 10:14:59 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2025 09:43:27 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2025 09:26:03 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/19/2025 09:15:48 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:44:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2025 04:28:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/14/2025 06:22:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
