EMA, page-14

My take from the draft report template is that it could mean any one of 3 things .

- is approvable...remarks to the notified body and recommended measures to the notified body
- could be approvable... provided that satisfactory answers are given to the "other concerns" as detailed in the preliminary List of Outstanding Issues.
- is not approvable... since "major objections" still remain, which preclude a recommendation for a positive opinion at the present time. The details of these major objections are provided in the list of questions.
That pretty well covers every possibility.

So what's different from yesterday that SP drops 20%?