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FDA submission? Haven't seen anything about that. EMA? This year? I'll believe it when I see it.
I mean, I hope I'm wrong, but over the last 9 years, except on maybe two or three occasions, Anavex seems to drop anytime "good" news comes out.
Btw, if you are insinuating that I'm anything other than a hopeful for the success of this company, you should do a little research into my posts. I'm a converted realist (maybe even pessimist) as Anavex's share price always seems to disappoint on news.
In true Anavex fashion, under $6, maybe even below $5.
Yeah, I even clicked on my name to make sure it was that easy.
Although they didn't submit the MAA, it was more than a conversation. They officially began the process by submitting the first form needed. "with the submission of the Centralised Procedure request"
Of course, you already knew this.
I wonder if this is the same Ana Ballout
- https://rettillinois.org/board/
- https://www.facebook.com/AnaBallout
Wainright buyer still has Monday to file if I am not mistaken.
Can you please clarify what makes this new? It says it was filed back in 2018.
Because I am a simple-minded person, can we take a moment and just summarize the current and future outlook?
-Anavex currently sits at around a $1B market cap (SAVA $3B, ANVS $750M, etc)
-Anavex is currently running a trial in Alzheimer's Disease that, based on Biogen's drug approval being in part because of biomarkers, is almost sure to lead to FDA approval assuming nothing drastic happens (something worse than brain swelling). In the previous trial, nothing remotely close to drastic happened, and Anavex has already been advised to move forward with the current trial as is, so it appears nothing drastic is happening currently
-The FDA is allowed to use clinical trial data from trials that have been completed outside the USA to determine eligibility for market approval if the trial was run appropriately (kind of like if the trial was performed similarly to the way it would have to be performed in the USA). Considering that Anavex has been in contact with the FDA and has been receiving guidance from them, I would assume that Anavex could still receive USA FDA approval with the way the trials are currently being run.
-Because the ALZ trial has sites in Europe, Asia, Canada, and Australia, I would guess that our possibility of approval in more than just the USA is far greater than if we were only running the trials in the USA.
-Anavex is also running what I would consider successful trials (safe and gaining information) in Rett Syndrome, PDD, and others. The Rett Syndrome showed promise and is currently being tested in a wide range of ages, with data readouts looming. PDD data was controversial (which we have now seen does not necessarily lead to not being FDA approved), and we are waiting to hear more data from that trial.
I am not going to sit here and pretend that the US Markets are completely fair and equal. I do believe that where there is money and there is power corruption is always either present or knocking at the door. However, assuming the market is completely fair and equal, I would expect Anavex to reach between $5B-$7B market cap by the time the FDA is set to announce its decision regarding Anavex 2-73. I would expect Anavex to reach a value of $3B-$5B by the time the Alzheimer's data is set to be released. So, between now and July 2022 I would expect Anavex's share price to grow from $15/share to between $45-$75/share (maybe a little less due to the raising of funds).
I think now is a great time to be invested in Anavex, because I feel that there is, at least for the next 12 months, very little downside for Anavex's Alzheimer's indication, which is a huge money-maker. We might hit a bump with PDD. I do not think Rett will be a bust, but it could turn out to not be as big as we hoped. But for the next year, Anavex will be getting closer and closer to a data readout that could mean 10's of Billions of dollars...I believe there will be a ride upward to take advantage of, even if one decides to sell before the news release.
I do think that Anavex will catch up to SAVA's market cap.
But, maybe I am wrong.
I noticed this a couple of days ago. I am not a technical expert, and to be completely honest, most of what I have learned about technicals has been from following Anavex and the many boards that talk about AVXL. Does this fit? Cup and Handle Definition
And the difference between your opinion and mine may be the cause of disappointment for you and excitement for me on Friday. I hope you are right; however, either way, I walk away happy.
By the way, since I didn't chime in before, I have been here since $0.19 a share in 2015 (pre-split). I was made aware of Anavex by JBem.
It is trading exactly how I would expect it to trade before known "pending" news. Those who care already know the data is positive and statistically significant. Hence why the price has increased from the mid $4's to the mid $5's. The problem is that the data could be just barely positive, average positive, or it could be AMAZING (trying the all caps thing...doesn't really do it for me---Oh, it's because I forgot to bold it and use a ton of !!!!!). Anyway, the stock is trading in a "we are at the price of positive data, so now we just need to wait and see how positive" kind of attitude.
If the data is AMAZING!!!!!!!!!!!! (nope, still doesn't do it for me), then we will see a quick price jump. If it is barely positive then we will fall back some. If it is average, then we will see a gradual increase in the price as we get closer to other trial endpoints and data readouts.
Unfortunately, many expect this stock to go sky high on Friday...the market already has priced in the data, assuming it is average. If it is amazing, the company will still have to do more studies, so we might see a jump in price, but most likely not sustainable (in my opinion).
I hope the data proves to be valuable in derisking the company's efforts in running the ALZ trial, thus giving the market more confidence in investing, and resulting in a gradual increase in price as time goes on.
I do not believe this is the same girl. The one in the news article is 5 years old. I do not believe the girl in the facebook link is 5 years old...I could be wrong. Please let me know if I am.
If you click on the link that he provided it will lead you to the study referenced. Scroll all the way to the bottom and you will see in italics "History of Changes" next to the ClinicalTrials.gov Identifier. Click on that link and press compare, and you will see what the updates are.
Anavex is listed on this one from 12/2019: https://www.secfilings.com/company/111915/filing/13926809
But not on this one 03/2020: https://www.secfilings.com/company/111915/filing/14155775
I agree, which is why I am confused about the discussion...
I am confused...why are we discussing whether we might be included in the index or not?
Click on "2019 Final Russell 3000 Index additions"
https://www.ftserussell.com/resources/russell-reconstitution
I absolutely agree. Definitely more complicated. However, I am simple minded. I do believe, however, that this is conservative enough to not set me up for disappointment when the number is much less than 80%. Let's be honest, 40% is still amazing!
Before stating my assumption, let us clarify. Missling has stated that ALL qualified applicants will be admitted for testing. Having a specific biomarker is not a qualification or disqualification, therefore, we should assume that the only non-qualified participants are the ones who meet one of the exclusion criteria listed at https://clinicaltrials.gov/ct2/show/NCT03790709?term=anavex&rank=5
That being the case, I gauge success based on 50% of the 80% of the population that has been shown to react positively to the drug. Since only 80% of the general population reacts well, and since applicants will be randomly assigned to only one of two doses, and since those who performed the best were those who were on the highest does, I expect
(450 * 80%) * 50% = 180 patienst, or 40% of total trial participants. This does not account for potential deaths, dropouts, etc.
I cannot find anything in writing that was put out by the company that agrees with you. I would be very happy to be wrong, though.
After taking a quick glance at the PR you mentioned, the clinical trials site, the quarterly report, and the pdd enrollment site, I do not see any reference to the spain trial having an optional extension available to participants. I will keep digging though. However, if it was never mentioned we shouldn't be expecting it. Hoping for it, yes, but expecting it, no.
Please correct me if I am wrong, but Spain is overseen by a different regulatory agency. So maybe they were not as comfortable offering an extension...I am uncertain.
"Anavex® Life Sciences Corp. is looking for volunteers to participate in a clinical research study to examine the effects of their experimental drug. Volunteers are important for the development of new therapies and advancing our understanding of Rett syndrome. In this clinical research study volunteers will randomly receive either the study drug or placebo. This design will enable Anavex® to assess the effectiveness of the study drug. Participation in this clinical research study may last up to twelve weeks."
www.rettsyndrometrial.com
"This study is part of a planned Anavex Rett syndrome program including placebo-controlled safety and efficacy evaluation of ANAVEX®2-73 over a 3 month treatment period."
https://www.anavex.com/anavex-life-sciences-announces-first-patient-dosed-in-phase-2-clinical-trial-of-anavex2-73-for-the-treatment-of-rett-syndrome-in-the-u-s/
I am inclined to agree with you, however, I do not believe we will see a price significant PR this week from the company. Also, in 2016 $AVXL rose about 100% after the addition to Russell (going from about $4 to $8), but that was most likely due to the binary event happening in July (which took us from the mid $7's to mid $2's).
I would much rather there continue to be a slow appreciation in price leading up to the end of the PD trial. Being added to the Russell will help with the accumulation, but again, I am not going to get my hopes up for a PR.
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Multiple Sclerosis, Biogen, and material transfer are not mentioned in any of the quarterly reports (10-Q) or the annual report (10-K) since the MTA was announced. None of those was mentioned in the previous 10-K either.
So, Amateur, how was it "removed"?
Has anyone confirmed that Anavex actually did present two weeks ago at the deal-making and partnership conference? It is listed in their events calendar as "attending" but they never PR'd a presentation. If you click on the link at the bottom-right of the events calendar page it says:
Poster will be up on Wednesday, November 1st, and presented on Thursday, November 2nd. It is a Theme 2 poster.
http://www.ctad-alzheimer.com/days-Poster-presentations
There is nothing to concretely suggest a deal is ongoing or even possible between Biogen at this point. One can speculate, but the conservative would assume (and base their investment decisions) off of MS being out of the picture.
Not necessarily a red flag, but disappointing.
Sloppy or on purpose? Conservatively speaking, one has to assume it was on purpose. Using 5-week p-values when there are so many months of data to draw from is a red flag for me.
It doesn't say anything about trials starting this year...oh no, I guess they aren't. (said sarcastically)
The PR is very vague as to what will be presented, not even words like "corporate overview" are mentioned.