Not exactly. The process allows for another clock stop at 180 days, which whilst TIS hope to skip through this with their latest due diligence of questions and answers, TIS's involvement with the CE mark has not been smooth going. IMO expect another few questions at 180 days because there is likely to be significant new information to be reviewed by the CHMP committee from this latest round of data collection.
The CE mark is not issued by the CHMP committee, they only provide an opinion to the European Commission which can deliberate for up to 67 days before making a decision on whether to award a CE Mark.
So if all goes well TIS still have 187 days left of the CE procedure/process once they finally submit their 120 days response. IMO Vitrogro sales in 2014 are no longer possible and I expect to see the Company recognise this once they make their 120 days submission to the CHMP committee and subsequent market announcement.
The above is all my own opinion and research. Please DYOR.
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Not exactly. The process allows for another clock stop at 180...
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