CE Mark, page-15

Hi J8, There is no question that VitroGro is a device. That was well and truly settled before the EMA started their review. It does however have pharmaceutical properties and imo this is why the EMA is being so thorough with their questions regarding the manufacturing process. They are also covering their collective arses! Last year they issued 82 positive opinions vs 3 negative, so it would seem that the odds are in our favour.

Quite agree with your opinion regarding the snail's pace of the regulators while patients are left suffering.