October CHMP Meeting

Apparently VG is back on the agenda of the October CHMP meeting:

(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. List of Outstanding Issues adopted on 25.09.2014. • Request from the applicant for an additional extension of clock stop to respond to the List of Outstanding Issues adopted in September 2014: For adoption

Seems strange we need to ask for an extension of a "clock stop". Why would EMA stop the clock on their timetable and then require a response within a short timeframe?

I'm not concerned by this as it appears to be normal procedure now (another device company has done the same thing). Although I can't recall it being mentioned before.

Still waiting for minutes from the September meeting.

Rev