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Wednesday, February 19, 2025 5:13:10 PM
Minutes from 2 more CHM meetings were released today – August and October 2024. Here are my key takeaways:
- We now know of 3 medicines that are "behind" DCVax-L in the approval pipeline – 2 from August, and 1 from October. Based on recent MHRA performance, we wouldn't expect to hear about approval on these 3 new candidates for several more months (although the 2 from August are both COVID medicines, so they might move more quickly).
- There were 2 medicines that had their second CHM meeting in this release, and they were both 6 months after their first meeting. So this indicates to me that they're still generally sticking to the 6-month gap between the first and second CHM meetings which I noted last fall.
- After adding in this new information, I looked back through the data to check for patterns in duration from second CHM to approval. Of medicines where we have dates for CHM meeting 1, CHM meeting 2, and approval, there are two main clusters – one where approval came roughly 3 weeks after the second meeting, and one where approval came roughly 3 months after the second meeting.
- If DCVax-L had its second CHM meeting 6 months after its first meeting (which to me seems likely, given the consistency of the timing over the past 2 years), then that meeting occurred on 12/19/24. That would mean that, as of today (2/19/25) we are 62 days past the second meeting.
All in all, for me this information seems to corroborate my previous observations and makes me more confident about where we are in the process.
- We now know of 3 medicines that are "behind" DCVax-L in the approval pipeline – 2 from August, and 1 from October. Based on recent MHRA performance, we wouldn't expect to hear about approval on these 3 new candidates for several more months (although the 2 from August are both COVID medicines, so they might move more quickly).
- There were 2 medicines that had their second CHM meeting in this release, and they were both 6 months after their first meeting. So this indicates to me that they're still generally sticking to the 6-month gap between the first and second CHM meetings which I noted last fall.
- After adding in this new information, I looked back through the data to check for patterns in duration from second CHM to approval. Of medicines where we have dates for CHM meeting 1, CHM meeting 2, and approval, there are two main clusters – one where approval came roughly 3 weeks after the second meeting, and one where approval came roughly 3 months after the second meeting.
- If DCVax-L had its second CHM meeting 6 months after its first meeting (which to me seems likely, given the consistency of the timing over the past 2 years), then that meeting occurred on 12/19/24. That would mean that, as of today (2/19/25) we are 62 days past the second meeting.
All in all, for me this information seems to corroborate my previous observations and makes me more confident about where we are in the process.
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