Replies to post #103034 on Anavex Life Sciences Corp (AVXL)

[attilathehunt]

If the results thus far are indicating there is a strong possibility that A2-73 is showing benefits that why isn't the Australian government providing AA along with further data gathering?

If everyone with insomnia is improving then why not allow AA with those suffering insomnia and track their improvement?

It's safe and it shows potential and there is a great need. Waiting another two years for another phase will result in many dying needlessly.

[McMagyar]

"Required"
My guess is with the Data Knowlwedge and Data wSharing now available FDA will make 21st Century medicine advances meaningful regarding placebo and blinds..
end the torture of ignorance or as I like to call them

"the twin lobotomy towers of modern Day medicine.."

[noretreat]

So when is the next trial? Ive been asking this now for at least a year.

[bas2020]

Falconer and others: Any thoughts about Axsome and its fast-tracked Ph3 drug AXS-05 (DM + BUP: Sigma-1 receptor agonist and more)?

AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. We are initially developing AXS-05 for the treatment of the following conditions: treatment resistant depression (TRD), and agitation in patients with Alzheimer’s disease (AD). AXS-05 is an investigational drug product not approved by the FDA.

http://axsome.com/company/overview-pipeline/?

TIA!

[ChrisMissing]

Hi falcon and I want to thank you for your ability to take the results and break them down for those of us who are less technically inclined. I do have a question for you I to believe that we are onto something special here and long-term everything looks great but why doesn’t Wall Street and the scientific community come out and have great things said about these results. Maybe that’s what will take place in the upcoming weeks based on this data or will we have to wait until phase 3 is complete. Looking back six months to a year ago I would’ve thought for sure we would’ve been sitting somewhere between a 1 billion and $2 billion market cap by now. Not sure what Wall Street is waiting for but I would love to see your timeline as to when we get valued properly thanks in advance.

[XenaLives]

I have long suspected that upcoming CNS guidance would make it possible to use historical placebo from a matched database sample. This would explain the delay, but it would be worth it because it would expedite the trial and save money. The Aussies may have the data to "make it so". Not sure how much data the U.S. database has that would be useful, but that is the direction CNS trials are going.

Yes, additional human trials are needed, for several reasons. A conventional double-blind Phase 3 study, with an experimental arm (with the real Anavex 2-72), and a control arm, where a physically identical placebo is administered is needed. FDA rules require such for eventual drug approval. FDA is “protecting us.” They want to be as certain as possible that adverse events (side effects) are minimal and not disqualifying, and that the drug actually works, with regulatory efficacy. T