TIS - EMA position may be reasonable, page-5

It is pretty clear (!) that no clinical studies are in prospect. The EMA's remit is over quality and stability etc.

The good thing is that instead of questions to answer they will have a negotiated method to obtain the kinds of data that the EMA wants. That's why it will be definitive. The EMA can't say "We wanted the data obtained this way not that way, or this way in addition to that way". And hopefully as these studies are lab tests they won't take too long to conduct and analyse (that is, similar time-frame as other data provide previously).