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damizo

04/02/17 10:12 AM

#8288 RE: hiwatt1959 #8286

Thanks

Warrior198

04/02/17 12:58 PM

#8289 RE: hiwatt1959 #8286

Is there a place we can get an update as to whether or not repros had sent the answers to the questions back yet? From what i gather...the committee asked the list of questions on jan 23..so repros has till apr 23 or 90 days to get the answers back to them. The clock starts at that time and resumes as day 120, so by june 23 the chmp could recommend enclomifene to the EU and july 23 the EU could approve, and the public would know after anytime after july 23. However, if repros sent the answers to the questions back to the chmp earlier then the 90 day deadline or apr 23...then the amount of days earlier they sent the answers back would be deducted from the july 23 day i posted earlier. The math shows that we could get EU approval earliest may 23 and the latest would be end of october. My guess is we will hear in july