AI
Friday, February 13, 2026 6:44:30 PM
So I have just completed a very extensive manual (no-AI) analysis of the CHM Meeting dates and Approval dates of ALL MHRA NAS MAAs that have been assessed to-date under strictly the National Procedure only, having discounted ALL reliance and cooperative MAAs completely. I might add at this point before I get bombarded with questions, I didn't use AI as I tried and it was wrong again & again & again when trying to ascertain the correct meeting minutes. It often made guesses as to the date of the minutes, but wouldn't even indicate that it was a guess. I have therefore manually parsed out the correct minutes for each treatment as best I can and double checked them accordingly. I believe they are correct!
Hopefully this will clear up a lot of speculation about CHM meeting-to-meeting and meeting-to-approval timings and finally give people the full details of what TunnelVision was talking about in his posts 1 year ago. Interestingly, once you remove all Reliance & Cooperative assessments there are in fact very few data points to look. Just 10 in total including DCVax-L. For 2 of them it seems information was redacted/ omitted from CHM minutes so we dont have sufficient timelines to make any due comparisons, which leave just 4 treatments that received Full Unconditional Approvals and 3 that received Conditional/ restricted population Approvals. I have attached a screenshot of my completed research.
Firstly, the ugly. The average time from CHM Meeting 1 to CHM Meeting 2 was around 159 days (shortest 125 days, longest 200 days). DCVax took 518 days...
But as ugly as this is, it has been confirmed that our assessment continues, which in my opinion can only mean we are definitely on track for an approval or a conditional approval. This much effort and time was simply not spent by everyone involved now to reject us now after 786 days and counting. You can all hash out the possibly reasons for this astonishing delay to your hearts content - not my fight!
For the 4 treatments that received Full Unconditional Approvals the range of time it took from the final CHM meeting to Approval was 36 days up to 110 days. As the only ATMP out of these 4, the most similar treatment to DCVax is mRESVIA, which had 3 CHM meetings, 200 days apart, 83 days apart and then 71 days until approval. mRESVIA from Moderna is an mRNA therapy for Lower respiratory tract disease (LRTD), which had a massive RCT with clear end points. Therefore, arguably regulatory decision making on this was easy and furthermore, Moderna was just off the back of it's Covid success and likely had the MHRA's ear so-to-speak.
The treatment that took 110 days from it's 2nd (and final) CHM meeting to Approval was the Prostate Cancer diagnosis radioisotope Illuccix. Reading between the lines I believe the long timeline was likely due to complicated radioactive logistics considerations that needed to be written into the RMP. Therefore, I have excluded and discounted it from due comparison with DCVax as I dont think they are worthy comparisons.
For Conditional/ Restricted Population Approvals the time from CHM to Approval announcement lengthens significantly to 154-182 days. We only have 3 data points to go off but they are all relatively recent and one of them, Aucatzyl, is an autologous CAR-T therapy which took 154 days. The other two (Kisunla and Leqembi) are are both very similar treatments for Alzheimer's, which both had red flags for safety issues and as such had to have population restricted approvals and mandatory patient testing to identify/ rule out specific patients (these respectively took 180 & 182 days). So if we concentrate on the CAR-T therapy (Aucatzyl from Autolous) it is similar to DCVax in many ways: dismal prognosis; autologous cell therapy; leukapheresis; high unmet need; ethical problems with RCT. Where it differs however is that it was a single arm trial with surrogate ORR as primary end point and no external controls arm. Therefore in it's conditional approval the MHRA designated specific obligations to verify longterm outcomes.
There was one other outlier at 235 days (Wainzua for ATTRv Polyneuropathy). Either the 2nd CHM meeting is omitted/ redacted or simply this was bang in the middle of the MHRA heaviest backlog period in 2024. Either way I don't think it is a particularly worthy datapoint to compare as it is not an ATMP.
Finally, there is Skyclarys for Friedreich’s Ataxia an extremely rare neurodegenerative condition and it seems all meeting minutes have been completely redacted or omitted, so no comparison can be made.
Therefore, based on the small amount of data to go on the two most interesting/ applicable datapoints are mRESVIA and Aucatzyl.
mRESVIA Comparison
So, for the sake of comparison let's say that DCVax is on track to get a Full Approval then we can project mRESVIA's timeline (which had 3 CHM meetings) onto DCVax. To go from meeting 2 to Meeting 3 took 83 days and to go from Meeting 3 to Approval took 71 days. So if we substitute 28th November as the date of the 2nd meeting and postulate that DCVax will also need a 3rd meeting then that would get us to February 19th. This year the closest CHM meeting date to that is 26/27th February. So 27th February plus 71 days gets us to May 9th. Of course, hopefully we don't/ didn't need a 3rd CHM meeting, in which case the approval date should (in theory therefore) be any day right now. What I do believe, is that the RMP and SmPC document preparations for an autologous therapy are massive undertakings and with very little past precedent to go on the MHRA simply don't have the manpower to get these done quickly so it will probably take longer than the 71 days for an mRNA ATMP. Today we are on Day 77!
Aucatzyl Comparison
Now, for the sake of comparison let's say that DCVax is on track to get a Conditional Approval (CMA) then we can project Aucatzyl's timeline (which interestingly only had 1 CHM meeting) onto DCVax. To go from the CHM meeting to Approval took 154 days. So, November 28th plus 154 days is May 1st. As to whether DCVax will get a Full Approval or Conditional Approval is another topic all onto itself. With it's low toxicity and the long tail of survival there are many positives for a full approval but ultimately I personally think it all depends on where the MHRA finally come down on the use of ECTs. If their final guidance (due to be published imminently) comes out strongly in favour of ECTs when there is a clear moral dilemma for using RCTs then there is a strong chance we will get a full approval.
I did also take into consideration the MHRA's published backlogs (as is shown in one of the columns in the spreadsheet) but they were supposedly cleared by October 2024, in which case they should not have affected either the Aucatzyl CHM to approval timeline or the mRESVIA CHM to approval timeline.
So based on this research and due precedent I believe we either get an approval before the end of February or if there is still no announcement by March then it seems likely that we will be looking at the beginning of May instead. The latter of which is a tough pill to swallow, but based on all my research I think there is essentially zero chance of a rejection at this point. I have researched precedent for rejections too and it seems to be that if we were on track for a rejection then we simply wouldn't have seen any mention of "a medicinal product used to treat glioblastoma (a cancer of the brain)" in the November CHM meeting minutes. For example Biogen's Aducanumab for Alzheimer's/ MCI got rejected by the MHRA and it is not there in any meeting minutes to review. Technically, very few drugs go all the way to a formal 'Refusal of Marketing Authorisation because companies almost always withdraw the application once the CHM issues a Negative/ Provisional Negative Opinion.
I hope this helps folks. The wait is excruciating but we genuinely are nearly there now! GLTA
Hopefully this will clear up a lot of speculation about CHM meeting-to-meeting and meeting-to-approval timings and finally give people the full details of what TunnelVision was talking about in his posts 1 year ago. Interestingly, once you remove all Reliance & Cooperative assessments there are in fact very few data points to look. Just 10 in total including DCVax-L. For 2 of them it seems information was redacted/ omitted from CHM minutes so we dont have sufficient timelines to make any due comparisons, which leave just 4 treatments that received Full Unconditional Approvals and 3 that received Conditional/ restricted population Approvals. I have attached a screenshot of my completed research.
Firstly, the ugly. The average time from CHM Meeting 1 to CHM Meeting 2 was around 159 days (shortest 125 days, longest 200 days). DCVax took 518 days...
But as ugly as this is, it has been confirmed that our assessment continues, which in my opinion can only mean we are definitely on track for an approval or a conditional approval. This much effort and time was simply not spent by everyone involved now to reject us now after 786 days and counting. You can all hash out the possibly reasons for this astonishing delay to your hearts content - not my fight!
For the 4 treatments that received Full Unconditional Approvals the range of time it took from the final CHM meeting to Approval was 36 days up to 110 days. As the only ATMP out of these 4, the most similar treatment to DCVax is mRESVIA, which had 3 CHM meetings, 200 days apart, 83 days apart and then 71 days until approval. mRESVIA from Moderna is an mRNA therapy for Lower respiratory tract disease (LRTD), which had a massive RCT with clear end points. Therefore, arguably regulatory decision making on this was easy and furthermore, Moderna was just off the back of it's Covid success and likely had the MHRA's ear so-to-speak.
The treatment that took 110 days from it's 2nd (and final) CHM meeting to Approval was the Prostate Cancer diagnosis radioisotope Illuccix. Reading between the lines I believe the long timeline was likely due to complicated radioactive logistics considerations that needed to be written into the RMP. Therefore, I have excluded and discounted it from due comparison with DCVax as I dont think they are worthy comparisons.
For Conditional/ Restricted Population Approvals the time from CHM to Approval announcement lengthens significantly to 154-182 days. We only have 3 data points to go off but they are all relatively recent and one of them, Aucatzyl, is an autologous CAR-T therapy which took 154 days. The other two (Kisunla and Leqembi) are are both very similar treatments for Alzheimer's, which both had red flags for safety issues and as such had to have population restricted approvals and mandatory patient testing to identify/ rule out specific patients (these respectively took 180 & 182 days). So if we concentrate on the CAR-T therapy (Aucatzyl from Autolous) it is similar to DCVax in many ways: dismal prognosis; autologous cell therapy; leukapheresis; high unmet need; ethical problems with RCT. Where it differs however is that it was a single arm trial with surrogate ORR as primary end point and no external controls arm. Therefore in it's conditional approval the MHRA designated specific obligations to verify longterm outcomes.
There was one other outlier at 235 days (Wainzua for ATTRv Polyneuropathy). Either the 2nd CHM meeting is omitted/ redacted or simply this was bang in the middle of the MHRA heaviest backlog period in 2024. Either way I don't think it is a particularly worthy datapoint to compare as it is not an ATMP.
Finally, there is Skyclarys for Friedreich’s Ataxia an extremely rare neurodegenerative condition and it seems all meeting minutes have been completely redacted or omitted, so no comparison can be made.
Therefore, based on the small amount of data to go on the two most interesting/ applicable datapoints are mRESVIA and Aucatzyl.
mRESVIA Comparison
So, for the sake of comparison let's say that DCVax is on track to get a Full Approval then we can project mRESVIA's timeline (which had 3 CHM meetings) onto DCVax. To go from meeting 2 to Meeting 3 took 83 days and to go from Meeting 3 to Approval took 71 days. So if we substitute 28th November as the date of the 2nd meeting and postulate that DCVax will also need a 3rd meeting then that would get us to February 19th. This year the closest CHM meeting date to that is 26/27th February. So 27th February plus 71 days gets us to May 9th. Of course, hopefully we don't/ didn't need a 3rd CHM meeting, in which case the approval date should (in theory therefore) be any day right now. What I do believe, is that the RMP and SmPC document preparations for an autologous therapy are massive undertakings and with very little past precedent to go on the MHRA simply don't have the manpower to get these done quickly so it will probably take longer than the 71 days for an mRNA ATMP. Today we are on Day 77!
Aucatzyl Comparison
Now, for the sake of comparison let's say that DCVax is on track to get a Conditional Approval (CMA) then we can project Aucatzyl's timeline (which interestingly only had 1 CHM meeting) onto DCVax. To go from the CHM meeting to Approval took 154 days. So, November 28th plus 154 days is May 1st. As to whether DCVax will get a Full Approval or Conditional Approval is another topic all onto itself. With it's low toxicity and the long tail of survival there are many positives for a full approval but ultimately I personally think it all depends on where the MHRA finally come down on the use of ECTs. If their final guidance (due to be published imminently) comes out strongly in favour of ECTs when there is a clear moral dilemma for using RCTs then there is a strong chance we will get a full approval.
I did also take into consideration the MHRA's published backlogs (as is shown in one of the columns in the spreadsheet) but they were supposedly cleared by October 2024, in which case they should not have affected either the Aucatzyl CHM to approval timeline or the mRESVIA CHM to approval timeline.
So based on this research and due precedent I believe we either get an approval before the end of February or if there is still no announcement by March then it seems likely that we will be looking at the beginning of May instead. The latter of which is a tough pill to swallow, but based on all my research I think there is essentially zero chance of a rejection at this point. I have researched precedent for rejections too and it seems to be that if we were on track for a rejection then we simply wouldn't have seen any mention of "a medicinal product used to treat glioblastoma (a cancer of the brain)" in the November CHM meeting minutes. For example Biogen's Aducanumab for Alzheimer's/ MCI got rejected by the MHRA and it is not there in any meeting minutes to review. Technically, very few drugs go all the way to a formal 'Refusal of Marketing Authorisation because companies almost always withdraw the application once the CHM issues a Negative/ Provisional Negative Opinion.
I hope this helps folks. The wait is excruciating but we genuinely are nearly there now! GLTA
