Replies to post #508793 on Anavex Life Sciences Corp (AVXL)

[Hoskuld]

If the company announces 2 3-71 250 patient P3 trials - total cost probably $50m - then those take 1 year and would be a move towards commercializing something.

Strange that the missed ADL endpoint was a big deal because that is not an EMA requirement and that is totally inconsistent with CM's claim that they were asked to submit an MAA based on the known data (and ADL slight miss was very well known a year ago.)

FWIW, it is already crazy low pricing: $120m cash on a market cap of ~$300m and 2 late stage standard-of-care candidates for huge indications that are extremely underserved.

[BakedLangostino]

"New Abclear data etc. was presented briefly."

Well, it sounds to me like the decision to reject had been made prior to Anavex even walking into the meeting. Clearly if they saw the ABCLEAR data, even just a cursory look, if it were truly that compelling to them they would have taken it into consideration.

I don't buy into 3D chess tactics or anything like that. It's pretty simple. Dr. M took a chance and it didn't pan out. The Detroit Lions coach did the same thing the other night against the Eagles. It happens. You learn and move on.

I believe we follow the path of AMLX, whose ALS drug was in a similar spot with rejection 2023: not enough confirmatory efficacy data. They are now running more P3 trials expecting results in a few months with a 2027 approval decision date. For what it's worth, AMLX stock dropped from around $18 to $3, and has climbed back to $14 today.

If we get a better outcome with the appeal, wonderful, but I am not banking on it. Mentally I am prepared for 2-4 more years of trials, with the possibility of a partnership offering some upfront cash sooner than that. We'll see. I do think that if Anavex can replicate its ABCLEAR2/3 data again in a proper P3 trial, the stock will still trade in triple digits even with additional dilution.

[Investor2014]

What cc with whom?

last post following a cc with Anavex one hour ago

[ImGettingBetter]

I would like to see a STICKY placed up on this board that documents this and any other pertinent info for what it will take to get a shot at approval in this current appeal PROCESS. Is FactaNonVerba 31 correct? Did he get the info from Clint on a phone call? I guess the CEO is not going to document that very basic understanding for his large retail invested in his company. The CEO job is to secure the company vision and goals and that is often done by keeping your shareholders informed and protected (if possible). I hope the upcoming 4th qtr conf on Tuesday 25 Nov, he will give good color on the process and what needs to be done in his opinion that will get this over the goal line. For pete sakes the stock can't go that much lower, so just fill us in. We already know what the short community is going to do.