Replies to post #104360 on Anavex Life Sciences Corp (AVXL)

[Reyeton]

This is an interesting statement:

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”

People with ALS had no real option, just like people with Alzheimer's Disease have no real option.

[Fireman02360]

"FDA in hot pursuit?"

Just maybe! It sure shows the FDA is viewing things much differently than the past.

This development alone has me even more bullish on AVXL. Is it possible that the FDA looks at the Aussie Trial,which has been going on for a very long time, and approve the drug based on efficacy and safety without a Phase 3, or possibly require a phase 3 but not make them go through the whole trial if things (data) go well after 3-4 months? I usually hate to speculate, but it does make me think. Everyone here knows I have been hard on Missling at times, but I think he may be onto something with the way the Aussie Trial (Phase 2A) has been designed and implemented. It could prove "pure genius" at the end of the day.

-Fireman