Saturday, March 21, 2026 4:00:11 PM
One more little thing to bolster the case for an announcement by/ before end April/ early May. Something I just noticed that had alluded me before:
In my original post I discussed mRESVIA, Moderna's mRNA therapy for Lower respiratory tract disease (LRTD), which I believe is the most similar treatment to DCVax amongst all other assessments that have followed the National Procedures pathway and which received a full MA 71 days after it's last CHM meeting.
mRESVIA however had 3 CHM meetings, 200 days apart, 83 days apart and then 71 days until approval. What I hadn't noticed during my original review is the time it took mRESVIA to go from CHM 2 to the Approval announcement (83 + 71) is also 154 Days. The exact same length of time that it took Aucatzyl to go from it's 2nd CHM to the Announcement! I do not believe that this is a coincidence. In both cases I reckon this likely represents the maximum aggregate length of time after the 2nd CHM (Clock-On Day ~150) that the MHRA (+60 clock-on days) and Sponsor (+90 clock-off days) are allowed to respectively use (plus a stop/start buffer time allowance of ~4 days) in order to remain within the statutory clock-on limits of the HMR 2012 Schedule 11 framework - regardless of whether or not there needs to be a 3rd CHM meeting!
We know from published minutes that DCVax didn't get discussed at the January 29/30th CHM. But it could have been discussed again at the February 26/27th CHM (which would be similar to mRESVIA's 83 day gap vs a potential 91 day gap for DCVax if it was discussed - the difference in which comes entirely down to the pre-planned CHM meeting dates). Based on the MHRA publishing schedule we wont know if DCVax was discussed a 3rd time until mid to late April as it takes 6-8 weeks. Nevertheless, whether DCVax is following a 2 or 3 CHM meeting schedule, I believe that the end result (if the maximum 210 Day statutory clock-on limit is used) will still be around the same time, end April/ beginning of May.
GLTA
In my original post I discussed mRESVIA, Moderna's mRNA therapy for Lower respiratory tract disease (LRTD), which I believe is the most similar treatment to DCVax amongst all other assessments that have followed the National Procedures pathway and which received a full MA 71 days after it's last CHM meeting.
mRESVIA however had 3 CHM meetings, 200 days apart, 83 days apart and then 71 days until approval. What I hadn't noticed during my original review is the time it took mRESVIA to go from CHM 2 to the Approval announcement (83 + 71) is also 154 Days. The exact same length of time that it took Aucatzyl to go from it's 2nd CHM to the Announcement! I do not believe that this is a coincidence. In both cases I reckon this likely represents the maximum aggregate length of time after the 2nd CHM (Clock-On Day ~150) that the MHRA (+60 clock-on days) and Sponsor (+90 clock-off days) are allowed to respectively use (plus a stop/start buffer time allowance of ~4 days) in order to remain within the statutory clock-on limits of the HMR 2012 Schedule 11 framework - regardless of whether or not there needs to be a 3rd CHM meeting!
We know from published minutes that DCVax didn't get discussed at the January 29/30th CHM. But it could have been discussed again at the February 26/27th CHM (which would be similar to mRESVIA's 83 day gap vs a potential 91 day gap for DCVax if it was discussed - the difference in which comes entirely down to the pre-planned CHM meeting dates). Based on the MHRA publishing schedule we wont know if DCVax was discussed a 3rd time until mid to late April as it takes 6-8 weeks. Nevertheless, whether DCVax is following a 2 or 3 CHM meeting schedule, I believe that the end result (if the maximum 210 Day statutory clock-on limit is used) will still be around the same time, end April/ beginning of May.
GLTA
Bullish
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