CHMP Meeting, page-33

There are more items in the 'opinions' section to oral explanations.

I presume this may mean if your in opinions it's likely to be a straightforward yes, and they are more concerned about spplications which they want an oral explanation from. Ie increased risk of knock back?

On the other hand there are 3 listings in oral explanations meaning maybe it's just standard procedure?

Rev - do you have any insights into previous reasons for oral explanations or affect on likely outcomes?