I'm more or less with you on this point.
The sample size is a little small for drawing real statistical conclusions, but... if we trim the high and low outliers from the pool of medicines that had their first CHM meeting in 2022 and have already been approved, the average time from first meeting to approval was ~191 days with a standard deviation of ~41 days.
1.5 standard deviations should capture almost 90% of outcomes (an expectation that is borne out by the data here). So, 1.5 standard deviations up from the mean takes us to 3/6/25. What does that mean to me? To me, that means that up until that specific date approval would be completely within "normal" range for recent MHRA performance. Since 3/6 is a Thursday, I'm just going to push the date to the next day for my personal deadline and make the statement that, based on MHRA's current performance, it would be reasonable to expect approval by Friday, 3/7/25.
What if approval is not announced by that time? Well, recall that we trimmed the outliers from the sample size. The high end outlier in this pool is Tarlatamab, which had a duration of 313 days between its first CHM meeting and approval. For me, that sets the upper limit for this process. 313 days from DCVax-L's first meeting would be 5/6/25. Since that is the longest precedented duration for MHRA's recent approvals, that is the point at which I would conclude that we were not approved if we had not yet received news.
TL;DR
- 3/7/25: This is the top range of the "normal" approval window. Reasonable to expect approval by this date.
- Between 3/7/25 and 5/6/25: Above "normal", but still within precedent.
- 5/6/25: If no news by this date, then we are in unprecedented territory (with regard to recent MHRA performance) and may not have received approval.
One last note as to the other medicines in the approval pipeline. Since mRESVIA has now exceeded the precedented upper limit (313 days), I have moved it from "pending" to "not approved" (I'm not claiming it has been rejected – I'm just saying it hasn't been approved yet and has gone longer than the precedented duration). This means that, for the 24 medicines in my broader pool, 19 have been approved, 3 have not been approved, and 2 are still pending. This yields an approval rate of 86.36%. The 2 medicines that are still pending are Illuccix and DCVax-L.
EDIT: One last caveat: If mRESVIA and/or Illuccix are approved, then these dates may shift as I incorporate the additional data.
AI
