You also have to add in 500+ or so investors who are LOADED to the gills like me with a whopping %.00024 for a total of another %10 percent of the company! AND WE aint goin NOWHERE NO HOW my friend! Ive been here through the GUT wrenching rollercoaster ride where I wanted to puke. It only made me stronger and wiser as I accumulated all along the way. I'm riding this gravy train until the last whistle stop! Whether it be in Germany (Bayer) or the US (Biogen), or Sweden.....! In the event we don't end up making it alone though and do get "absorbed" by a large pharma hopefully its a stock swap so no taxing takes place.

GL and God Bless my friends!

Tred

Investor I'm quite sure BP is very aware of this and is having a hard time playing chess against Dr. Missling right now. "They" are having a hard time keeping the price down allowing accumulation as pointed out several times by Zena and others. Raise the price too much and bargaining power is lost. Don't accumulate shares and risk being left out in the cold altogether. If the final plan is to use the rest of the shelf to fund phase 2/3 and get us closer to approval (possible accelerated approval) than more power to him,...I VOTE YES! 5 Billion partnership now or 10-15 Billion partnership later next year, who the heck cares about that 50 million shelf used to get us there? I for one will not be looking back after a $150-$300 share price in 2-3 years.

The top is going to come off this thing pretty soon. Too many irons in the fire getting Rett HOT! :)

Tred

I see what you are saying Bio about all the forces coming together for the common good instead of working against each other. I couldn't help but feel the opposite though about 6 months ago when I decided to start calling and emailing dozens of Dementia Dr.s and organizations up and down California letting them know about the CTAD conference in San Diego. As I scrolled through dozens and dozens of organizations on the internet I came to the conclusion that there are so many livelihoods at stake here. Soooooo many foundations and care centers working on cures from handouts by BP's and Gov grants that may see us as a threat rather than a "partner".
If ever there was someone to help "bridge" the gap Dr. Missling would be the guy. He has reached out to a few of the major organizations so far for their financial help in advancing this drug for a cure to their disease. Ive read a story sometime back about how difficult the MJFF was to work with in a recent promising past trial. They were trying to take control of am upcoming trial for a promising drug when felt that a Dr. wasn't planning it properly. Navigating these waters and reaching out to large pharma "sharing" to some degree a piece of OUR pie, on OUR terms, is not how they are use to working but may like you say be the best way forward, having everyone on the same page for the common good for humanity. Who knows, maybe we will become the next JNJ and be "absorber" of new promising Sigma 1 receptor baby Bio's that we spawned through our own release of our research.

Your welcome by the way about St. Augustine's quote. Its my favorite simplistic but powerful quote I like to use when I come across a person that has a tough time understanding the Bible. They try picking it apart word for word,... sometimes missing the forest for the trees. Or something like that :)!

Tred

Biostockclub can you imagine not only the transfer of wealth but the transfer of POWER we may soon see as clinical trials progress towards approval. That has to have some of the "inner" circles (BP heads) chattering and probably has yet to hit or sink in to the larger "outer" (Dr.'s and care facilities that push the BP agenda)circles!
IMO our CEO has done a remarkable job fending off the attacks and kept his nose to the grindstone. Never mind all the small talk, its just set up for a distraction to the REAL truths that are forming with the NEW tsunami of a paradigm shift happening.

If I'm not mistaken it was in the words of St. Augustine, "I believe, in order to understand; and I understand, the better to believe." Some times for us there is a leap of faith in order to understand better. May God Bless Dr. Missling and all here that believe that this company is headed on the right track and......SOON!

Tred

Thanks Xena. You are right, I remember reading that. That means that would free up cures act money for other pipeline projects like non-opiod pain management!

Tred

Well said Jimmy. That is why we are where we are price wise imo. Missling is going against the grain with his path to market. We have yet to see who trump puts into the head FDA position yet but every bit of "grease" helps when you are up against big Pharma and their money machine institutions.
Imo we have multiple tools we have been using that will help us get to market:

the new Fda trial design that we we used
Dr. Misslings financial savviness to navigate around the secondary
using his experience to partner with organizations

whats still needed IMO:

Cures Act money for Alz. for a US trial
Trump tearing down barriers for safe and effective drugs.

I'm very satisfied that we are in good hands right now.

Tred

Thanks for the link Bio!

So these funds buying in have realized that there is no secondary because the good Dr. Missling lined up us with operation capital ahead of the majority of the clinical trials. Also he is or has funded all trials to date with funds from organizations and or other governments. Let us all hope the US steps up and funds an ALZ trial with money from the Cures Act. If they didn't that would look pretty bad considering how much Dr. Missling has presented in front of the NIH and others and how advanced we are in such a small trial nagainst such a horrible disease!

#adaptiveopenlabelFDAapprovedtrial

Tred

If Ariana can start to tie positive commonalities of "therapeutic responses" (like one of the recent slides showed from Nobel Conf.), across multiple diseases, all the while dialing in with "precision" dosage amounts.... we may have the drug of the century. Platform baby! All of these upcoming trials, through their designs, will be for indications with very short lived efficacy results, with great CONTINUED cost controls.

Dr. Missling is and always will be 33% of why I invested EARLY and heavily with this company. One look at his pedigree and even I could see "winner!, winner! chicken dinner....SCORE! Who here thinks the good Doc is over paid now? That these conferences are for traveling around and taking vacations on the company dime,... now? Humility, straight forward science and clear thinking is what he is about. Thats the only way something this big could actually work. This may be .....EEEEUUUGGGGee!!!

ok I will put away my pom poms now

Thanks Neiu for this information! I now know why Ms. Christina Capiak has been silent for so long,.....lol. She has probably been working her but off filling out all those Cures Act forms! I think we have too much to offer with our data from our Alz trials not to get some form, path of accelerated approval. Patient testimony and safery alone should heavily sway the FDA. Can you imagine a video of the guy/gal that went back to playing golf.....by THEMSELVES!

Something has to give way sooon!

A big thank you again to the Moderators and those that have contributed to this positive board. Much thanks for carrying us lay persons through (imo) these "short" lived hectic volatile times!

Tred

Anything of material value would require a PR, would it not? What is the time frame they have to release a PR after material is out? TIA.

Also fwiw, I have full confidence in Dr. Missling. This is a very narrow and uncharted road he is traveling on. They being very meticulous and methodical in their actions and are not letting the cart get ahead of the horse here, IMO. Obviously we as shareholders will hear when the time is right.

Tred

Almost seems like we are in the "eye" of the storm. We have lasted the lawsuits, uplisting, phase 2a results and "insults". I'm sure Missling knows this and is readying the ship for the next re-entry of the wall of fury!
Anyone that thinks this is going to be gravy after the announcement of phase 3 is kidding themselves.

Tred

I am wondering for those that may know, aside from children in rhetts and adults in parkinsons is there big differences in the two diseases. Don't both lose motor skills and have uncontrolled convulsive type actions? My point is that I am wondering if the Parkinsons trial will have a short 90 day efficacy trial like Rhetts? If so wouldn't that be a great next Pr for Missling. A %80 funded trial from MJFF for PK. Then to cap it all off, a MS trial starting and partnership news in a Ph 2/3 with Biogen in ALZ.

Keep lining them up DR. the pokers are getting RED HOT!!!!!!

Tred

I was first in opko at 4.50-5.0 range some years ago. I was a true believer and still am to some degree. I liquidated my position after the first big drop from 14 down to 9 ish. While I am still optimistic about opko one does have to wonder about management of this company and how time and again they miss targeted goals. Frost buying doesn't do it for me anymore as an investor. I understand the concept but he doesn't need the money and probably never will. I will look to jump back in after some gains in a few others but will not be in any hurry given the current climate. I do however feel for those that are still hanging on.
Who knows maybe tesaro's milestone payments will start kicking in and boost quarterly numbers!

Tred

Ariana is impressed with Anavex too....

“We are very impressed with the rational and efficient clinical trial path Anavex has embarked upon by adopting population pharmacokinetics (PK) and adaptive trial design in its current ANAVEX 2-73 Phase 2a study in Alzheimer’s disease,” said Mohammad Afshar, CEO of Ariana Pharma. “Ariana has the expertise to fully support Anavex’s precision medicine approach to develop more effective treatments for devastating diseases including Alzheimer’s, Parkinson’s and Rett syndrome.”

With Ariana on-board this 12 week double blinded placebo trial will be a fast but thorough trial leaving NO DOUBT in FDA's mind for Accelerated Approval.

Stay thirsty my friends!

Tred

I agree Ziggy about the patent of A 2-73 plus. So Rhett may get us to market the fastest and then Alz trial with the results of A 2-73 plus patent comes into play with "pooled data". Why promote monotherapy when we can pool the data for a MONSTER patent. Then the companies resources can be freed up to run what, maybe some heart disease trials, insomnia etc? Also the A3-71 orphan designation trials will be moved up the list with upfront payments from partnership. We were also invited to speak at the recent roundtable for non-opiod pain management with A 1066 so the good Dr. is laying a very broad foundation for either a VERY healthy partnership or a larger ship!

This recent partnership with Ariana IMO is here to stay and if we can stay independent from takeover I see this company continuing to run MULTIPLE, very efficient trials through partnerships with organizations. We are talking about reaching 10's BILLIONS, through further validation in other indications, of revenue with in a decade.

HE is meticulously crafting a BIGGER SHIP!

Tred

This is the next 5 PR's I see happening:

1) Patent of A 273 plus

2)PArtnership with ___ge_

3)Start of phase 2/3

4)Rhett syndrome phase 2 funding

5) MS trial update.

Any of these will start the clock ticking for the shorts!

Tred

Could it be that the delay in the Dr. heavily promoting is patent issues? I think they are close to working out the details on the patent with the FDA but as some here have put it, we ARE going to "need a bigger boat". Why get the cart ahead of the horse. With the FDA guiding Anavex on a phase 2/3, remote possibility (but still a chance) of Accelerated approval leading to approval about 6 months into(?) a phase 3, wouldn't you want the patent and partnershipto be aligned?

Tred

Thanks again Neiu! Its like Dr. Missling is at the helm of a mile long train, of extremely important cargo (drugs) , with 6-7 main engines (drug trials)! While it takes some time to get the train moving, once it starts moving (with trial starts)it will not stop! Wow! When will Ariana's data start to surface helping to ACCELERATE this drug to market?

Look out shorts! That whistle you hear in the distant isn't always what it appears. Big things do come in SMALL packages and while this ALZ trial may take a year or more, Rhetts, (possibly) Parkinsons, and Infantile spasms will not! EVERY trials data continues to SUPPORT the HOMEOSTASIS that is happening in the brain.

chug-a, chug-a, chug-a, CHOO! CHOOOOOO!

Tred

As I scrolled through Ariana's website I happened to look at who they were partnered with and one name stood out in particular,...Sanofi. Where did I see that name before? Ahh yes that was where Dr. Missling worked at before joining Anavex. They are listed in the "Personalized Cancer Treatment" section of "Industrialized Partners".
While this might not mean much now, I believe Ariana is HERE TO STAY as we rapidly apply their technology to the unfolding of "...many phase 2/3 trials up and running in 2017"(paraphrase)

http://www.arianapharma.com/portfolio/imodi/

This was also of interest on their page:

(underline added by me for emphasis)

An integrated solution
Using your data, Ariana combines baseline characteristics, gene expression, protein measurements, metabolomic data and any other relevant data you provide, and ranks each combination of these data points, showing you the most important to your trial.
We dig out more meaningful relationships than other approaches, without relying on outside databases, or resorting to “data fitting” as is too common.

Better patient response
Knowing the attributes that describe your best responders allows you to refine your Inclusion/Exclusion criteria as part of your Adaptive Trial, or for your next clinical phase of development.
Greater patient response rates reduces the number of patients needed to meet your endpoint.

Experience counts
Ariana has identified valuable and meaningful signatures in multiple clinical projects in cancer, neural diseases, rheumatology, ocular diseases, metabolic disease, childhood diseases, renal, anti-viral, anti-bacterial, among others.
We provide more than just data analysis, we help you see what others miss. (color added by me for emphasis)


http://www.arianapharma.com/services/clinical-data-analysis/

Just a little longer before the first horse is out of the gate!

HAPPY NEW YEAR!

Tred

Hess Thanks for posting that well organized compilation of the many potential future catalysts. JOB WELL DONE!

Tred

Good Morning All! A big thank you for the moderators of this board who have helped keep this board a civil place to follow and discuss Anavex as developments have occurred, EXTREMELY VALUABLE!
On another note does anyone know when we might hear about whether or not we have a piece of the "Cures Act" pie. Is is tied to or triggered by the trial starting that funding may have been allocated for? I am still holding out hope that this is the funding mechanism for Phase 2/3 for our Alzheimers trial. At the very least! With the latest roundtable and data delivered we may be looking at multiple trials with a funding source.

Good luck to all longs.

Tred

I seem to always forget to paste the link for some reason, a duh moment. The drug is called Rayaldee and is created by Opko Health.

http://investor.opko.com/releasedetail.cfm?ReleaseID=976439

Tred

Plex, the speed with which I see Missling lining up these trials, for pennies on the dollar, through partnerships amazes me. He is getting into the right circles with respects to the Gov., drawing in top Phd's in fields of ALZ, PK, etc to his SAB. His methodical approach to "diversify" this drugs entrance into the market is remarkable.

On another note,I wonder if someone else might know whether or not any other company, in a phase 2a, has used the FDA's adaptive open label trial for AZ where we could compare the outcome. I believe the FDA came out in 2010 with this new approach of a trial to quicken failure or positive results. If not, than we are in uncharted waters with respects to the FDA (accelerated?)approval process, power of results, use of historical placebo data.

Regarding the 10 billion price tag, IF this were a one trick pony than that would be a valuation on the high side at this stage(one could even argue that with that Heptares deal), but being that we have MULTIPLE INDICATIONS that we are targeting, well than that very well in a year may be a lowball estimate!

GO ARIANA! GO AVXL!

Tred

Is a perfect storm brewing?

Missling states that a partnership would be 6-12 months out,....12 months ago.

Anavex retains some top of the line council some time ago. Perhaps when partnership negotiations started or just legal council for the bogus lawsuit??

Never before seen results at 31 weeks in ALZ trial.

BOD renews Misslings contract handsomely.

Multiple Phase 2 trials lining up to start in 2017.

"quiet period" is necessary due to partnership neg. This whole time we are waiting for partnership news and it may be that is "locked up" until what, Biogen test for MS proves positive?

NIH presentations,....Cures Act signed sealed and delivered!

Biogen signs MTA for MS, perhaps to round out the deal with anavex for MS, PArkinsons, Alz, Retts......

Ariana is working overtime to connect the dots in ALZ for, what proof for....FDA accelerated approval?

FDA is seeing the same data and more as patients have been on the drug for almost 2 years.

New Ceo comes in for Biogen who is talking about rapidly boosting pipeline.

MILLION DOLLAR QUESTION: Who gets to make the announcement? Missling or Biogen's new CEO about the.....wait for it.....1 share FOR 1 share partnership? That's only 10 billion. In 5 years that will be a drop in the bucket especially if Anavex announces Accelerated Approval for ALZ!

p.s. sorry for the slight rambling and that everything is not necessarily in chronological order. Ihub has been slow lately since that DDOS attack.

Tred

Todays the day Dr Missling should have a PR waiting in the wings.....like funding for phase 2/3 or something strong enough to put these idiots in check. HIT THEM IN THE WALLET I SAY!

TRED

I agree MC, while I was hoping for a bit more too I found myself being really impressed with all the points he made in the presentation. If not a partnership announcement in the wings maybe he is waiting on Obama to sign the Cures Act so he can CONFIRM and share the funding mechanism for at least one of the Phase 2/3 trials. In 2016 this company has grown leaps and bounds with respect to clinical trials and scientific validity. Its ALL THERE! Its just going to take a bit longer than everyone would like. Ariana is also still in the background diligently working combing through the results........any day, any week , any month!

Tred

How about a 1 for 1 deal with Biogen, and Missling becomes CEO with his current team in place. In 5 years with his leadership and AVXL's pipeline BIIB would be knocking on JNJ's door in size!

Id take it, nothing less.

Tred

Did the President sign the Cures Act yet? RELEASE THE HOUNDS! Over 3 billion in "brain" research! We HAVE to have been given a piece of that pie to cover our Ph2/3.

Tred

What are all these talks about 1-2 Billion? THERE IS NO WAY our Good Dr. is going to allow ANYONE to walk in and scoop this up, PERIOD! Heptares was was given a partnership for 3 billion for a phase 1b. I'm sure he is very familiar with ways in which he is able to ward off a buyout. Especially when we have been manipulated and hammered down to $3! we should be at atleast $8-10 and holding! Nope this is soon to grow in value with awareness and unless a partnership (ONLY) is in hand like the good Dr. has mentioned than we are looking at the 10-15+ billion in a (partnership)with further validation, I don't care where we are sitting today!

imo

Tred

if the CC Missling is talking about is tied to that this would be the ULTIMATE trap for shorts! Go ahead, play with the stock price MONDAY! We will see how you like us on WEDNESDAY! Great feeling about the next two weeks. With the recent participation in the second "roundtable" I really think we have secured some kind of financing in the Cures Act. When does Obama Sign it? If Monday of Tuesday would this give Missling the GREEN LIGHT to announce whatever is in it?

OOOOHHHYAHHH BABY!

Tred

Good Morning All! I just took the time to contact either by phone or email 7 major alz, dementia care centers in CA with the CTAD in for on Anavex. Many of them may well be at the conference but incase they weren't, I figured I would expose them to the compelling science that is unfolding.
As I was typing I was not sure if this would ultimately be received, long term, as good news or not with many of them possibly having to change careers.
Oh well we need to GET THE NEWS OUT!

Good Luck and may God Bless all longs that have supported this company through thick and thin!

Tred

What happened, did the HFT machines BREAK? Are the MM's out of TRUE and ACTUAL shares? What happened to the volumne?
Certainly feels different going into this conference. I am looking forward to Saturdays long awaited PK PD data and Mondays market reaction.
Here's to 2-3 PR's next week!

Tred

I like those numbers NWDR! I like how conservative they are too with only %25 market penetration. This may take 4-5 years but with the right partner, with networks set up in the right countries, we are talking multiples of that....for just one indication!
I remember when Gild bought Pharm asset, they took a lot of heat from shareholders from the sticker price shock. Look how it has bloomed for Gild. I honestly believe if we can stay independent we have a much better chance of bringing the full potential of our pipeline to market and the FASTEST under Dr. Missling.
An interesting note on Pharmasset, Dr Ray Schinazi was a co inventor of their lead drug. Take a look at what he is doing over at Crystal with Dr. Frost and Teva. New best in class HPV drug!

http://ir.cocrystalpharma.com/press-releases/detail/30/cocrystal-announces-positive-interim-data-from-an-ongoing

Ticktockticktock

Tred

Neiu, I am not familiar with how these CTAD conferences roll. Are there Q&A sessions afterwards where she might provide updates on FDA "stuff"? Wouldn't this require an 8k if she were to announce or provide information? I am just wondering if there is any other reason to have her along besides the good ol' gaining "experience" factor.
I have to admit though, Missling is presenting in front of the right groups and getting sheate done in my book! The NIH and this other Gov. roundtable today are very good groups (with lots of ties to our money) to be kicking the can with, especially with a safe drug that has a unique mode of action! While I am not happy with the high 3's, I would MUCH rather have the stock price be where it is and have the momentum of "coming news" with a drug that works than be in Axon's position anyday! Even with FDA "FastTrack" for their (failed?) drug, I wouldn't touch that stock with a ten foot pole even if the street paid me. I watch it go up and then right back down. I can picture a hedge fund or two trading back and forth HOPING AND PRAYING for a small morsel from the FDA to bilk investors out of another BILLION or two.
Speaking of "FastTrack" status, so Biogens failed theory and Axovant failed plaque theory both receive FastTrack from FDA? Man its not like the FDA is desparate or anything is it? I mean come on, this is only Alz we are talking about. People's head swelling and falling out of trials and they are giving them incentives to "press" on. I am a firm believer that A 2-73 is going to be accepted early by the FDA with an ongoing trial to prove it out. JMHO!

Also, anyone know when the senate votes on the Cures Act?


Tred

I haven't seen this stock trade this low of volumne and sustain a pps in a long time! It would either pop on no news and run up just to crash down. Someone or something is getting ready to happen and perhaps has a few nervous to the point where the games have stopped,...for now.

#MAXED OUT on AVXL SHARES!

Tred

I agree MC. I think Dr. Missling just put his 9 millimeter away and upgraded to a rocket launcher! NO MORE BULLETS! We are going to launch "MISSLING MISSLES" at the cabal!
I hope Ariana has been able to play catch up and maybe even beyond 52 week. Makes one wonder if the FDA had any input with respect to Ariana and their FDA approved program. Say,.....With Anavex applying for Accelerated approval and the FDA saying "no not yet....but if you apply this and it shows up,...than!"

just sayin! There is a reason for the beautiful Ms. Capiak to be there in attendance!

Tred

Year over Year D. Missling has achieved quite a bit Imo. Look how far he has raised the bar not only with Alz trial but on MANY fronts. Its easy to sit back and drive from the back row but make no mistake, he IS in it to win! Would I have done a few things different? You bet, we all probably would have including Dr. Missling! IMO, in light of the fierce headwinds that the Pharma industry has thrown at us with bringing this kind of revelation of science to market, little ol' Annie has done just fine. Most companies would have been forced to sell half their remaining stock at pennies on the dollar just to get through ph2 a.......! Not the BRILLIANT Good Dr.!
I just cant get the slide in the spring presentation out of my mind. The one that shows A 2-73 in the middle and ALL the target indications around the circle with checkmarks by some. HE/WE ARE bringing those trials, for those indications, to light, and on a shoestring budget.
So as I wait for this week to pass, I am comforted in the thought that even with ALZ aside, WE HAVENT SEEN NOTHING YET! With the continued exposure that Anavex will get,.... there will be a giant SUCKING sound of companies, organizations, and gov.'s wanting to get in partnership with our little $4/sh company.

Tred

Multiple doses?
Maybe Opko Healths "CTE" technology it acquired when it bought Prolor would be of benefit. Dr. Frost has and is applying it to many things including vitamins and various drugs to keep them in the blood stream longer. I believe it extends the half-life by double in vitamins and drugs like Vitamin B called Niagen by Chromadex, Vitamin D called Rayaldee by Opko, HGH CTP (still in ph 3 trials) by Pfizer, and Niraparib by Tesaro. All are showing great confidence in results. Might be a WONDER DRUG in combo with A 3-71!

Maybe I will drop Good ol' Dr. Frost a line.

Tred

I agree MC. The fact that the graphs at 31 weeks showed improvement but management didn't support it is what confused shareholders and the "market". The line was there but no data! I believe its through additional time, Ariana and an improving graph has bolstered confidence by actually giving the FDA, Management, and possibly Dr. Perry the PROOF they needed. They see the patients getting better , they just couldn't prove it clinically yet.
Question, with two extensions why are patients still not on optimized dosage yet.
Optimistic that our CEO is going to fire MISSLING MISSLES at the market come Monday Dec. 12th.

locked and loaded

Tred

I'm not afraid to put a number on it.
100 shares bought today IMHO, based on research done on BIIB, CELG, REGN, etc....who started out with one drug for ONE indication, we as shareholders after accelerated approval in 1-2 years can expect a 2 for split for 5 consecutive years in a row, MINUMIM!, for just ALZ! This in MY opinion puts us with partnership at a valuation for the 100 shares in 7 years at a conservatively priced $50,000 and in as high of $300,000. Now if all those 2017 Phase 2 trials, with Ariana's FDA approved algorithmic program, continue to show a clean safety record, one can possibly assume that in possibly in 5-7 years we are all taking A 2-73 for a "maintenance" drug to prevent one indication or another, you can multiply that high price time 3. Minimum merge of 1 for 1 with Biogen but I agree if we can truly stay independent per Misslings early communicated path, we are going to be able to BUY Biogen!

WORD!

Tred