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NotSure2

05/12/24 10:19 AM

#690826 RE: JTORENCE #690820

There is aprox 86 trial sites ( +/- 10 if I misscount). Majority of the sites are in the USA.

https://www.clinicaltrials.gov/study/NCT00045968#locn

Hopefully MHRA have like 3-4 teams to review all of these sites, and they dont have to go to each of them. I.E they can review half or more of them at a central location (documentation) with schedule Zoom/Team meetings with involve party that participated in trial (if they are still alive/not retired)

And only inspect the ~20 busiest sites?

Thats the only way we could see approval in June.

If there is only 1 or 2 inspection teams, and they need to go at each of these site, then thats going to take a loooong time.

July-Aug-Sep for possible approval?