We weren’t there, so we cannot know what actually transpired. I’m not saying Missling is lying but maybe that was his interpretation. It would certainly be unusual for a drug regulator to directly tell a company “you should file.” I believe that would be a conflict of interest, because regulators are supposed to be impartial. Their role is to evaluate a drug candidate filed by a sponsor, not promote or encourage a specific drug approval application.
Who is doing the pulling? The EMA by "soliciting" the MAA? The unmet need in EU? The lack of MRI facilities? Can you not at least admit that IF cornered Missling could not testify that "so and so at the EMA said by all means we want you to submit a slam dunk MAA"? Even Steady's suggestion
After looking at the data the EMA most likely said "we like what we see, you should file so we can take a deeper look because so far your data looks approvable."
is a step too far for a regulator to take....IMHO.
Anavex is still live in the procedural sense. There is an unmet need WORLDWIDE. IF and WHEN CHMP renders an opinion it will be based upon their review of the Anavex submission...NOT upon the "and there's this" and "we think there is reason to believe" statements and PRs from the Company.
With 50% of MY target exposure at present I could cut my cost basis this time around to just under $10, but I see no urgency to commit in the mid 8s.
This week's REAL NEWS coming from CHMP won't move the needle. Reflection on whatever statement may be forthcoming will take more than 3 or so hours of a Friday closing bell.
BTW (IMHO) you make my point that Missling even given the benefit of the doubt rarely speaks in certainties. It is not MY definition of sufficient that you should seek, but that of EMA and Missling.