Awesome news! With this, the approval rate for new non-IRP medicines in my sample is up to 91.3%; of 24 candidates, 21 have now been approved, 2 have not been approved, and 1 is pending (DCVax-L).
This single data point gives me a huge amount of confidence in approval. Simply put, medicines that appear in the CHM minutes are approved at an overwhelming rate.
Here are a few more observations:
- As of today, 2/28/25, we are sitting at 246 since the first CHM meeting. As I've mentioned before, for the next 2 months we are well within the precedented "normal" timeframe for approval. Of course, some applications can take much longer (mRESVIA took 371 days from 1st CHM meeting to approval) – but these cases are extreme outliers.
- With mRESVIA's approval, there are now definitively no applicants "ahead" of us.
- From the August and October CHM minutes, we know of 3 medicines that are now "behind" us. If those medicines are approved close to the mean timeframe, we wouldn't expect to start hearing about them until May at the earliest. Approvals certainly could come sooner (especially for COVID medicines, which generally seem to proceed more quickly). There also could have been medicines addressed at a September meeting that are now in the mix; we won't know until those minutes are released. However, in order for any of those medicines to be approved before DCVax-L, they would have to buck the trend of longer non-IRP approval timelines since IRP approvals started rolling in.
- At least 1 non-IRP medicine has been approved every month since IRP approvals ramped up last fall.
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