Replies to post #399347 on Anavex Life Sciences Corp (AVXL)

[JWC3]

I believe we will, just remain open a while longer. More results are about to appear. Perhaps the EXCELLENCE trial enrollment as well will be done. Once EXCELLENCE trial is done all will be caught up and amazing progress will begin!

[mike_dotcom]

I'm at least very encouraged by some of the more mainstream press finally noticing - Forbes and Zacks have published positive pieces. I would hope the FDA guys we hired are working toward approval. But I'm with you - when?

[plexrec]

avxllent--" So why the holdup?"--have also been wondering the same--just read an answer TGD gave to a question he received at the recent JPM Healthcare Conference--this I saw in a transcript from the conference--tried to copy the answer to post here but unable to--basically-paraphasing the Dr.--Lots of detailed intricate analysis going on--very detailed---will pass on all info "very soon"--put my angst a bit to rest as to why "so long"?? I understand better now this is very technical analysis going on !!!!!

[Gator328]

Probably December 2023, + or - a few months.

[nidan7500]

Beginning to Question When This Happens?

avxllent

Most/many of us have same questions. IMO, the likely/possible explanation for delay would be the complexity of the integrated systems which MUST BE in use. # of notified-certified bodies, number of independent systems used by different regulatory bodies in different countries (even very minor errors will STOP the train. Each one must be verified and validated , including instruments used and reviews of training/certification of every 2nd/3rd party.

The list of what must be done, by whom and when is long and (likely) continuously in flux. I have done such multi national V&V work as many others here may also and would say (countries/languages/hw/sw/v&V of each system ) not to mention patient variables and local/in country practices all are factors in why this type of multi country./multi system /multi regulatory body/international trial is not even attempted (never mind on a CNS disease as complicated as AD) .

My guess is Dr.M.'s answer might be..."It will be published when we finish and not before" ...

[nidan7500]

What could possibly go wrong???

The latest Lilly trial results gives a partial explanation..."they ran out of WHAT???"

https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html

Avxllent:https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html

[blue finch]

Wow
You're just posting this today ?

[WolfofMia]

All I can say is listen to FRROL, and act like a patient investor.

Or call IR like he did and get back to us with what you hear promptly.

If it can be unrealistic expectations, even better!!

Thank you in advance!

Beginning to Question When This Happens?

[abew4me]

Warren Buffet's Advice for a Volatile Market

"If you aren't willing to own a stock for 10 years, don't even think about owning it for 10 minutes!"

https://www.marketwatch.com/story/warren-buffetts-advice-for-a-volatile-market-patience-pays-11643223497

[mrplmer]

Calling IR is purposely worthless. Clint is a puppet. You won't get an answer from him that will satisfy you!

[Hoskuld]

What, specifically, are you referring to as the "this" that you want to pin a date on?