News Focus
News Focus
icon url

Investor2014

01/21/25 10:46 AM

#481172 RE: Guzzi62 #481169

Not if EMA doesn't find the P2b/3 trial as sufficient for full approval. This because a P4 trial is generally open label and paid by patients, as its purposed is to underpin an accelerated/ conditional approval in terms of log term safety and efficacy. Anavex have applied for full approval, so their data has stack up as pivotal for that.
icon url

boi568

01/21/25 11:46 AM

#481187 RE: Guzzi62 #481169

I am trying to imagine a world in which the European Union, faced with a looming public health and financial crisis due to the lack of a good Alzheimer's drug, would turn away blarcamesine for years on the basis that, while efficacious, safe, and convenient, it leads to more low grade transient dizziness than desirable when titrated during a two to three week period rather than a ten week period. Nope, that's too stupid to imagine.