Thanks Puzzled for the research. I started to do a little myself and then got bored. Before I gave it away I looked at 5 months of oral examinations at the start of last year - a sample size of 15 applications.
10 received a positive opinion at the following meeting or the one after that (66%)
All but 3 received a positive opinion eventually (within 6 months of the oral)
4 still had outstanding issues after the oral (all 4 received a positive opinion eventually)
4 received a negative opinion after the oral and all asked for a re-examination. They got it within 5 months but only one of these was ultimately successful
At least 1 application was found not to need an oral after all as they had addressed all the outstanding issues.
Hope all that helps in some way. I agree with Puzzled that we're comparing here against some pretty nasty drugs. As far as I can see CHMP has never required a "device" to go through this oral examination procedure.
Rev
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