agm notes for the more discerning, page-5

The huge price tag is what will protect scenesse from mass use.
Together with the implant delivery via doctor, the epp diagnosis this will maybe form enough protection of european public health for EMA to accept MA.

Never will ema accept a systemic drug on the market that could end up being used by a large audience.

In that light also it is important to notice the development of CUV9900 as a non-systemic localised external use only co-therapy to scenesse. (for vitiligo in the first place?)
Maybe the vitiligo trial cannot start because they want to use cuv9900 in these trials and that is plan not ready yet because the regulators did not accept it yet. Not to disrupt the negotiations with the much press-aware egos of the ema it would be better not to mention any of this in the open.

Many of the delays with cuv are due to long negotiations with regulators. cuv management is more keen on not accepting just what is said by regulators but challenging them with new ideas to bring them closer to what cuv wants. Mostly that would mean a gain in time since it allows to start later but already at a more advanced stage or with a more interesting set up. e.g. the start of phase II in usa in stead of phase I, the waiver for paediatric trials,
the cuv9900/vitiligo trials would not take 2 years to finish but could be done in just 2 or 3 months. So its worth to negotiate a bit longer before starting. Vitiligo is a very local skin problem so a non-systemic/lower risk drug would be more appropriate. The successrate is easier to assess and trials could be much shorter. (no need for sun exposure)