News Focus
News Focus
icon url

underpar71

02/12/25 11:37 AM

#748936 RE: StonkMaster #748934

When was their application submitted and validated?
icon url

KRISGO

02/12/25 11:40 AM

#748937 RE: StonkMaster #748934

Do you know when the company submitted for approval, and how long it took to receive it?
icon url

JTORENCE

02/12/25 11:58 AM

#748944 RE: StonkMaster #748934

StonkMaster Everybody but NWBO. Ladies, Gentlemen and whatever's, something ain't right with this picture and it runs deeper than that which meets the eye.imo
icon url

tunnelvisionofplenty

02/12/25 12:05 PM

#748948 RE: StonkMaster #748934

Nice!

This medicine had its first CHM meeting on 4/25/24, 2 meetings prior to DCVax-L. There were 293 days between its first meeting and today. (Incidentally, that proved to be exactly 2.5 standard deviations away from the mean based on recent MHRA performance.)

DCVax-L is currently sitting at 230 days since its first CHM meeting. However, in my eyes what's more important is that I believe there are now 0 medicines "ahead" of us in the approval pipeline. For the 24 medicines in the pool I've been tracking:

- 20 have been approved
- 3 have not been approved (including mRESVIA)
- 1 is pending (DCVax-L)

As I've mentioned before, I believe that no new medicines were addressed at the July 24 CHM meeting, so August would be the earliest any other medicine could have been addressed for the first time. Medicines can and frequently are approved out of order, so it's far from impossible that we could get approval news for another medicine before DCVax-L – though looking at the numbers, that seems unlikely. It's also possible that we could still get a mRESVIA approval sometime, too.

That being said, the runway appears clear for DCVax-L approval next.