Minutes

Just in case anyone is interested the minutes of the September CHMP meeting have been published. They don't tell us anything new apart from confirming that a "specific timetable" was given to TIS to respond to the outstanding issues. I guess this is what provoked the application for an extension at the last meeting. It's also interesting to note from the September minutes the details of what happens when a positive opinion is given. This occurred for 2 devices at that meeting. Here's the text relating to VG:

(EMEA/H/D/002831), ((substance to be reviewed) insulin-like growth factor-i (igf-i) segment), (hard-to-heal wounds, primarily venous leg ulcers), List of Questions adopted on 23.01.2014. The CHMP adopted the List of Outstanding Issues with a specific timetable. The Committee adopted the BWP Report.

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