Ann: Shareholder Update January 2019, page-2

They are still not prepared to divulge if it was in fact a CRL they received and most definitely are steering away from the word 'trial' :

The meeting, which is expected to be scheduled during the next six-to-eight weeks, will allow the Company to clarify what clinical data will be required and whether this will be through the generation of new confirmatory clinical data, or whether the requirement can be satisfied by additional analyses of existing clinical data.

"new confirmatory clinical data" IMO can only mean trial ? How else do we obtain new data ? Happy to be wrong here, but how else do you get "new" data.... I also believe they had to word it this way 'legally' to support the content of the announcement on the 27th December ? Again IMO