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Re: hiwatt1959 post# 8282

Wednesday, 03/29/2017 7:09:27 PM

Wednesday, March 29, 2017 7:09:27 PM

Post# of 8473
Im not an expert on the EU approval process but from what i understand, the EU accepted repros' submission of enclomifene on october 5th, the 120 day period ended and the CHMP had made either a favorable or unfavorable opinion of enclomifene on january 23rd and forwarded that recommendation to the EU commission. I read that now the second phase, which is the decision making process by the EU commission has begun..am I reading correctly that now that they have received the recommendation from the CHMP they will have 60 days to either approve or reject enclomifene for marketing in the european union?
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