Awesome, nice find! I was not confident about flibanserin for this one, but hadn't been able to turn up another candidate. Unfortunately for the applicant, this MAA was probably declined. IRP candidates seem more likely to get approved within the statutory timeframes – sometimes even well within them. IRP-B (the pathway this medicine was on) has a timeframe of 110 days. Delgocitinib (approved 12/10/24) won approval via IRP-B in just 59 days. It has now been 313 days since Lawley said they submitted their application; it has also been 202 days since their CHM meeting. (Coincidental that those dates are 111 days apart? 🤔)
So, they are now no longer ahead of DCVax-L in the approval pipeline. There are now (in my estimation) a maximum of 2 medicines ahead of DCVax-L: mRESVIA and gallium-68 gozetotide.
I do not intend to add AndroFeme to the list of 20 medicines, since it was ultimately submitted and declined via IRP. I haven't been including IRP medicines, since they have quite a different review process. I can say that a number of IRP medicines have been approved in recent months (you'll find them as you scroll through the MHRA's news & communications page), but their approvals happen so quickly that the announcement comes out long before the CHM minutes are released.
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