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Replies to post #743540 on NorthWest Biotherapeutics Inc (NWBO)
01/13/25 3:17 PM
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although when drugs aren't approved I've often seen the NICE status updated to reflect that the drug was completely withdrawn from consideration so that may not be the case here)
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.
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The application was withdrawn after the European Medicines Agency had evaluated the information from the company and prepared questions for the company.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
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
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)
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.
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]
01/14/25 1:57 PM
tunnelvisionofplenty
Monday, 01/13/2025 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).
01/22/25 12:30 PM
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%)
AI
