Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Flying Alb, can you tell us if the PSs passed?
Well, I'm guessing nothing earth shattering came out of the meeting based on the crickets and the SP.
Did the preferreds pass or not??....Anyone??
Interesting, I thought because of the X and Y chromosome factor, boys didn't survive Rett.
So in your opinion , how does this affect the agreement between CF and Anavex if any.
It seems to me that most Wall Street are a little shady.
Was Scott Gotlieb an ally of ANAVEX or somewhat of a road block?
It didn't seem like things moved very quickly under his watch, or was he up against a lot of old school red tape.
Not sure what to think about this. I hope that this doesn't cause more delays!
Up 48cents- 21% pre-market! Somebody likes the report
On the subject of the boost in manufacturing, does anyone know what is the shelf life of a drug like A2-73?
Just voted my 35k....YES for all
The point that struck me was that in the example, they envisioned improvements starting in only five days!
I would have thought that it would take more like five weeks to start having an effect.
Hypothetical Example!
Interesting.. only 5 days!
EXAMPLE 3
Seizure Reduction
[0064] An 18 month old female presents with Rett syndrome. She experiences 6 to 10 seizures per day prior to commencing therapy. She begins treatment with oral doses of A2-73 at 2 mg daily. After 5 days of treatment, the number of daily seizures is reduced to 3 or fewer.
I added a few thousand myself in the 1.50 range!
Thanks tax loss sellers
There is still a question about how involved in the foundation,groups and head trial investigator that he can be with an unbiased opinion while being employed by Anavex.
I'm sure that this was well thought out before accepting a position with Anavex.
Perhaps Dr. Alan Percy will assume the duties as Principal Investigator.
Have you ever envisioned, Missling, Hampel and Fadiran arranging a private meeting with Bill Gates and giving him an hour or two presentation on 2-73 and 3-71 and how this different approach to AD along with the precision medicine method, might be what he is willing to support?
Who knows, maybe it has already happened!
I just added a chunk. Keep um coming.
Let's see what kind of return 1.60 brings in three years!
Great news indeed! Looks like we have finally turned the corner!!
Go Anavex!
So what are everyone's thoughts on this Alzheimer's vaccine? Is it a serious threat to Anavex or to far down the road to be concerned about.
From what I understand, sometimes companies like Anavex will take a pass on smaller grants from foundations like MJFF because they lose control of how the trial is conducted ,with the foundation calling the shots.
Knowing Dr. Missling's management style, I wouldn't doubt that this might be the case.
Dr.M stated the 3-71 would be in the clinic in 2019, let's hope so.
Yes, but what about A3-71....
Hope so. I have always thought of A2-73 as Anavex 's opening act and 3-71 will be the real prize. Possibly even a reversal or "cure" for some CNS diseases.
"All of the questions raise significant red flags. Flash, Doc, Investor and Steady you are all valuable contributors and cast a doubt on the viability of the drug and its' efficacy. You are very helpful in showing the uncertainty associated with this risky investment. Fear of being duped by sloppy presentations and unclear data raises the possibility that this will be thrown into the dustbin of failed AD drugs. Thank you for alerting us to the potential pitfalls. This is much more than healthy skepticism. You are doing your job helping all of us who are less knowledgeable in interpreting what is presented. If we did not have the benefit of all your education and expertise we would be left to take what the company said as fact and not the uncertain results that you so accurately articulate. Thank you for all your DD and as a result I am much more skeptical of this risky investment. "
" All patients who participate in the study will be eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol. This study will be followed by a planned placebo-controlled safety "
Can someone explain what this means?
THX
Anavex Life Sciences Announces FDA Approval of IND for Phase 2 Trial of ANAVEX®2-73 in Patients with Rett Syndrome
Do you think maybe,just maybe Fadiran and Missling have been working with Gottlieb this whole time. It would explain the extreme lack of communication and issues that don't seem to make sense to us like the trial registrations and the Rett delay.
I guess that we will find out soon.
So no North American arm? Looks like the entire trial will take place is Australia.
Probably means a quicker trial than involving the FDA or Canada.
Wow, seems everything is doom and gloom lately.
Patience!
Missling stated at the conference on Wednesday that A3-71 is scheduled to be "in the clinic" in 2019.
Any thoughts on what indication is might be for?
Frontotemporal Dementia perhaps or possibly AD?
IMO , A3-71 is going to be the mega blockbuster of Anavex's future
So.. what is your deal Kentucky?
Being sarcastic I hope
Longs are going to have to pack a big supply of patience to see this play out. Hopefully we wake up to an unexpected surprise one morning that we didn't see coming.....or maybe news of the Rett trial starting
Are you saying that I am a short?
"we are probably 1 year from full enrollment in Australia and at least 2 years for any data. "
A little disappointing to hear to say the least. So when the company says trial "start" in 2018, what they really mean is a start of the year long process of recruitment. Readouts in 2 years?? What happened to TGD talking about possible readouts by the end of the year? The trial isn't even registered in AU yet!
This has nothing to do with delays with the FDA.
And then there is the quick 12 week Rett trial that will be the "fastest to market " path. Already at least a year behind schedule and we don't have a clue what is happening there.
I am still long and have held all of my shares since before the RS and have been adding for the past 3 years.
However, I am starting to understand why we are sitting at 2 bucks a share.
I have always supported (and still do) Missling, but I am starting to believe that there is a bit of "over promise and under deliver" happening.
It's looking like any near term good news is going to happen with PDD in Spain. Someone posted about recruiting going well and should be a faster trial. Let's hope so.
So I will continue to hold and try to be patient for this to play out.
Good luck to all AVXL longs
Hnbager
Excellent post Sokol! Mods please sticky.
If A2-73 is approved in Australia, with a trial arm conducted in let's say Canada, what would be the process for being approved in the U.S.?
Is there some type of lengthy review process?
If the FDA Doesn't Get there act together, it seems wise to conduct all of our trials outside the country.