It's premature to be talking about the FDA and EMA in my opinion. We are still months away from any potential NDA or MAA filing, assuming that they happen at all. We don't even know if any data supports filing a NDA/MAA and for what indication(s). NDA/MAA approval is a long process. For example, Amarin still hasn't had Vascepa approved for cardio indication yet despite REDUCE-IT reporting top-line over a year ago. And there is no guarantee of approval once a NDA or MAA is filed. Any discussion with the FDA/EMA at this point in time would have to be under the confines of a confidentiality agreement and likely just for information gathering purposes to find out if it is even worthwhile filing a NDA/MAA. Meetings/communications at this point would not be for determining drug approval, only determining if an NDA/MAA should be filed and for what indication(s). All just my opinion. I am no expert.

BearDownAZ