Just in case anyone is interested the minutes of the September...

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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