Doc, thanks for everything and we enjoy your continued presence here. One more thing to add in the list you gave is this. FDA proposed that guidance document last December and it is still in the process of being finalized. I am counting on it to show up in the federal register any day now, hopefully before Data Lock but for sure before TLD in July. Hope Hahn's quarantining doesn't delay its release. I view that as our approval in the bag once published.
Thank you for all your contributions! Much appreciated!
You wrote:
I think there will be some sort of news before November about an application to the MHRA and an expected timeline for an answer for approval and NICE recommendations
I agree 100%! I found additional information (UK and other places) but I’m still missing a few pieces of the whole picture. I wonder if you can post a link from:
- the MHRA authority (the expedited review list)? - AWMSG (All Wales Medicines Strategy Group)? - SMC (Scottish Medicines Consortium)? - DoH (Northern Ireland’s Dept. of Health)? - others?
NOTE: I understand if you are not allowed to post some information on ihub! Thank you!