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09/05/18 8:30 AM

#188390 RE: Lykiri #188388

Lykiri,

Funny how that November 8, 2018 NICE Appraisal Committee meeting date pretty much lines up with 3 years from last patient enrolled and 3 years and 3 months past the last patient surgery in the Phase 3 trial. Best wishes.

flipper44

09/05/18 10:30 AM

#188400 RE: Lykiri #188388

However, for cancer therapies, NICE can proceed with the first appraisal committee meeting without a CHMP/EMA regulatory decision (not the case with MHRA though :-) ). So the November 8, 2018 meeting is not necessarily critical from CHMP/EMA perspective. -- https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/process/sta-timeline

Week 21

For non-cancer topics the committee meeting cannot go ahead until the CHMP opinion is published.



Not certain why you chose "other" regarding my prior timing question. Anyway, again why is the final scope not confidential right now? Under the rules only the draft scope can be released prior to MHRA regulatory approval and a known price.

Again, looking more and more like MHRA regulatory approval is mysteriously at play here.