News Focus
News Focus
icon url

FeMike

01/13/25 6:34 PM

#743579 RE: tunnelvisionofplenty #743574

The first thing that comes to mind is that maybe it’s common for applications to be denied prior to the first CHM meeting, in which case they wouldn’t appear in any of the minutes. But who knows, there may be some other explanation.



I appreciate the DD and info here.

Just an fyi for you, this scenario isn’t necessarily possible.

The MHRA isn’t allowed to outright reject an application. If they recommend rejection, it must go through a CHM review first as a matter of procedure. The only way to skip CHM review is with an outright approval.

That being said, I don’t know how things work behind the curtain. Maybe if MHRA want to reject, rather than going through a CHM review, they can simply relay to the sponsor that they would recommend withdrawing/resubmitting. Who knows.
icon url

Horseb4CarT

01/13/25 7:37 PM

#743586 RE: tunnelvisionofplenty #743574

If it looks like a duck, and walks like a duck, and quacks like a duck, then it's most likely a duck,.... exit stage right:-)

DCVAX L is most likely a duck..... I mean following in the (waddling) footsteps of the other 90% of the treatments that have been approved after appearing in the CHM meeting minutes, as you infer!!!!

Didah didah didah that's all folks!!! :-)
Bullish
Bullish
icon url

exwannabe

01/14/25 10:11 AM

#743649 RE: tunnelvisionofplenty #743574

Thanks for digging up and cross referencing the approvals.

To e clear, I was not suggesting you were being selective. I was suggesting the disclosure time frames might be.