Regulatory approvals are not generally made of too small defective trials that do not meet all their per protocol endpoints, have titration/tolerability issues and can't show dose dependence. Then two years later gets presented with statements such as an OLE can replace the need for a confirmatory trial, only to now have that OLE data presented in ways that has left doubt about it conclusions and isn't accompanied by the most basic chart clearly showing what is going on.
What the regulators and market wants is solid data that shows the drug works and with safety, where benefits outweighs the risk. Anavex haven't got clear proof of the former. People here read far too much into an MAA having been accepted by EMA.
The market is not in general as silly as this MB and it is reflected in the price of $AVXL. It is not impossible that the totality of data including the MRI brain volume could help in the context that the AD indication is in with the MABs, lack of efficacy and safety issues.
In my view things look a bit more difficult now based on today's presentation not really putting a clear stake in the ground. As I of course keep saying we should know more by August. The AD/PD conference in between won't help - I see no clever reason to hide OLE wonderfulness to later.
All unfortunately in my sincere humble opinion. I would so much love to be proven wrong and we actually get bonus approvals for both Alzheimer's and any kind dementia imaginable - the absolute silliest topic of today's message board nonsense!
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