Replies to post #389478 on Anavex Life Sciences Corp (AVXL)

[boi568]

The difference here is that the Biogen drug was worthless. The FDA will be eager to approve a good drug against Alzheimer's.

People should understand the FDA's mission, which is "Protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products." It is not to oversee the development of drugs to the greatest extent possible. They understand the perfect is the enemy of the good.

What we know about blarcamesine after this trial is that the FDA should welcome its submission. There is a lot of public health to be timely protected by not requiring a lengthy second trial of a safe, efficacious AD pharmaceutical.

[Fireman02360]

yeah that's if a large phase 3 isn't needed

I suggest you do a bit of research on the whole precision medicine thing. FDA is/has been huge on this using bio-markers/DNA,etc. It revolutionized Oncology (smaller powered trials using PM biomarkers) and it will be acceptable here as well. Particularly with very good PH3 results and a drug that has proven to be very, very safe and well tolerated.

Stuck in the past much??

-Fireman