Missling has told us that Anavex has had meetings with EMA staff and given them much more than just the top line AD2b/3 data. It seems that there's been a preliminary EMA review of that data. That is normal EMA protocol; nothing special there. Obviously, one purpose of these meetings is to allow the EMA, with a minimal amount of effort, to screen out future weak MAAs that would waste their time and resources during a year-long plus process.
I want to do a little math here. I have seen Doc and a couple of posters say Anavex has now only a one percent chance of success in Europe. As I recall, the EMA accepts about 90 MAAs per year, and its "positive opinion" rate, after taking withdrawn applications into account, at worst, is about 85 percent. (See my post 440099 and my reply to that post.)
The EMA, after the meetings and preliminary look at Anavex's data, has green lit our Centralised Process request. There is now no identifiable regulatory obstacle to our submitting an Alzheimer's MAA, and no identifiable reason for Anavex to fail to submit one. Our chances of receiving a positive opinion should today approach, or stand at, about 85 percent. This number is not an opinion, it is a published and easily determined regulatory fact.
But perhaps there is a statistical one percent chance of success for companies first approaching EMA staff for their preliminary consideration of supporting data. I doubt that, but one percent is not my prediction here. Suppose further Anavex, after the green light, is not yet out of those dark woods and our chances stand now at one percent because we need still to convince EMA staff of our bona fides.
In that case, the EMA staff, which annually reviews about 90 MAAs per year, would, at this stage of the process, have to wade through 85 times that number to find the viable applications -- an absurd and unbelievable 7,650 annual data reviews and a multiple of that number for meetings.
So we know that our one percenters have no stats that back them up. (Nor does Investor, stubbornly stuck at 25 percent no matter the season.) They are not privy to the full AD 2b/3 data, subsequent complete dives into biomarkers, etc., or OLE results. They are not current EMA decision makers. They do not claim to have any such inside information, or experience in conducting EMA reviews. They have their reasons to post that prediction, but since it's not based on facts, they don't explain it. They just state their nonsense as if it's true and hope you fall for it.
