My reading is that in order to get approval (for the CE Mark)...

My reading is that in order to get approval (for the CE Mark) additional data is required "to determine a definitive solution". That is, CHMP has indicated at the meeting that if the data is provided and arrived at through "studies" given the okay by SAWP (at the meeting in May) that no more questions will be asked and an opinion will follow - favourable if the data is satisfactory unfavourable if not. We will find out after that meeting the timeline involved.

The Update does not tell us what the additional data pertains to. But it must be something that CHMP wanted prior to authorization.Because we don't know what sort of data they want it is difficult to speculate about the timeline. But given it would not be about efficacy but only related to product quality related to manufacturing, shelf-life etc. one would think that these would not be long and involved. Similar perhaps to the data sets required from previous questions. By having the method of obtaining the data agreed to by SAWP there should be little chance (but not zero!) of CHMP being further dissatisfied by the amount of data or questions about how it was obtained. So, I'm going to be optimistic and suggest that it will mean a delay of a few months and that the definitive opinion will come early in the second half of the year. The company has the funds to do this.

I am annoyed that the update does not say why they are withdrawing the application for Scientific Opinion. It does follow from the request for additional data - see the phrase "Given this" in the update. I suspect that apart from the additional data they wanted something more - perhaps lengthier studies on efficacy - in order to grant a satisfactory Scientific Opinion (for sales outside EU). Anyway, it does not affect authorization for the CE Mark and sales in the EU.

How the company provides information to the market and the nature of that information will determine the share price. It will be interesting to watch volumes and price over the next 2 months. Moreover, if those in the know have a favourable opinion about the end-game (they know what data is required that will please CHMP, how to obtain it, and likelihood of it being obtained) then there will be a shift in shares from the uniformed to the informed.