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.
Peer review takes as long as it takes. I have seen some peer reviewed papers that were published in 2 months and some that took 2 years.
All that the company can say is that it has a paper in the process. How long that process takes is out of the company's hands.
We are dropping because the Rett trial did not come out as expected. There is no significant news expected in the near to medium term, as a result there is little buying pressure. So the share price drops. Of course the fact that the overall market is taking a beating at this same time is a contributing factor.
If you find this scary then you need to reconsider why you invested in Anavex. Is ti fun? Is it enjoyable? Is it desirable? No to all of those.
Is this being invested in a biotech based on ultimate outcome? Yes.
I suggest Growaset.
If that is the case then the LOI was filed in November. That starts the 7 month clock to the submission of the MAA.
What part of a calendar do you not understand?
When was the first mention of the EMA by Anavex? Do the math.
I have no information on the LOI status.
SHMP up 89% as I type on vol of 20.45 MM shares.
Has it been 7 months already?
16.6 million shares traded today and the SP is up 58%. Something is up.
This is an article that may be getting closer to root causes of many CNS diseases including AD.
https://phys.org/news/2024-02-undruggable-proteins-approach-neurodegenerative-diseases.html
I didn't see any non approved drugs mentioned in that article. So not seeing Anavex is not surprising.
I suspect we won't see much mention of Anavex in the main stream press until there is at least a NDA filed.
Very interesting article. It sets the stage for 2-73 to be used as a prophylactic if it can get approval.
Interesting that the numbers are so low about those going on to get clinical symptoms of AD after this test diagnosis. 23%.
That leads to the question of how many needed to treat to prevent a case. We have seen with the statins that a very high number of people treated to prevent one death and that has been found acceptable.
The other thing that jumps out at me from this article is that the causes of AD are still not really known. This looks to me to still be searching for earlier symptoms and not finding causes. Given the low progression rate, assuming that continues to hold, it becomes clearer that Tau and plaques are late stage factors and not root causes. In a way this should help drive a nail into the coffin of Beta Amyloid plaque and Tau as targets for treatment and prevention.
So how's that 11 millions shares workin' out for ya?
We have been through this false argument multiple times
The bulk of the shares owned are in various index funds where the fund manager has little choice about which companies and how many shares to own.
A significant number of shares are in various discretionary funds where the fund manager is able to choose which stocks are included in the fund. It is those discretionary funds that are adding shares.
Many of the index funds are market cap weighted which means when the funds rebalance a stock with the share price drop should result in the fund selling shares.
What we are seeing is the total number of shares owned by the large money manager funds is increasing.
If you read through the list of outcome measures it looks like most of those will be taken care of in 4 visits. There will be a follow up visit some time after the trial is complete.
So it doesn't look like that trial will be that onerous for the patients and caregivers.
I think you exaggerate the difficulty just because there are a lot of measures.
I suggest you take your own advice.
That is not what he said. He said they "could" be so good that the FDA" may" immediately approve Anavex 3-71 directly from this Phase 2 trial.
Which is clearly a guess. Just like your guesses of "We could get a big upside surprise coming out of left field but it sure doesn’t feel that way.
He uses the caveats that you do. He just does so in a positive direction while you go the other direction.
Not exactly a big problem. Be well.
You might want to spend a little time with Google before you make your posts about what the FDA does and doesn't do.
What is that saying? Something about the pot calling the kettle...
The phrase is " will be for naught". But aside from that you are correct. Like any other company it has to achieve a successful product to achieve a beneficial outcome.
I think your use of the word dilutive is misapplied.
Anavex is a pre revenue company. Its only source of funding is shares sales. That is what the capital market is for.
For me the term dilutive means that there is no value returned for the shares sold. If there is value obtained for the shares being sold then I don't see that as dilutive, I see that as an appropriate use of company assets and shareholders money.
Currently the shares sold are being used to develop drugs that when approved will generate significant shareholder value.
If the shares being sold increase the overall value of the company is that dilutive or is that increasing the value of the shares?
Right now the share price isn't very good. If it stays that way long into the future it will be because the company has failed not because shares were sold increasing the OS. If the company gets 2-73 approved the share price will be significantly higher than any decrease due to the impact of selling the shares that got the company to the point of generating revenues.
The company has maintained that $150 million in the bank for several years. It does so by selling shares to maintain that balance. There is no reason to think that will not continue for the foreseeable future.
To paraphrase your long post it essentially says, if everything goes to hell in a hand basket the company might not survive.
I bought 1500 of those shares today @ $5.60
So there were no BUYS today?
I mistook the acronym MAA to mean it was an EMA application not a UK application. I didn't grasp the MHRA signifying the UK.
The UK does in some few circumstances count business days but for the MAA application they count calendar days.
The EMA counts business days.
My bad.
The FDA will be the judge of that. If the FDA considers the trial a failure it is likely that the FDA will require an additional pediatric Rett trial.
My point, which you seem to be overlooking, is that the Rett program is not dead that is what the poster I was responding to said.
You are willing to put a stake thru the heart of Rett at this time. I suggest that is a mistake. The status of Rett is not known until the FDA renders an opinion.
If the FDA says go ahead and file an NDA then things are back on track. If the FDA says run another trial then AD should be full on.
Even so, Anavex has the resources to run multiple trials at the same time.
At this point AD is at the NDA preparation process stage, not running trials stage so the cost is manageable. Running the 3-71 trial along with an additional Rett trial would not be a huge cost. Fragile X trial will not be a long trial and will likely not require a very large number of subjects so its costs will also be manageable.
Two things will determine Missling's ability to raise money at a reasonable cost. The FDA Rett decision and the contents of the AD peer review paper.
Until those items are known Anavex and the SP is in a holding pattern IMHO.
To use your argument, the heightened expectations of the placebo group should be the same for the treatment group. After all, it is unlikely that the subjects knew which arm they were in. If you claim that the kids and care givers in the treatment group were able to figure out that they were in the treatment arm then it would seem that they had lowered expectations compared to the folks that had not figured out which group they were in i.e. the placebo group.
The reason given by the company for the strong placebo response ascribed it to different levels of disease severity between the two arms. The random selection process when selecting small numbers from a larger population can sometimes result is a less representative group being selected. A larger selected group tends to generate a more representative group of the larger population.
Validated biomarkers for Rett would be very helpful in this regard, as you say. Unfortunately the genetic changes found between the treatment group and the placebo group are not yet validated biomarkers. At this point they sure are suggestive.
To quote Elon Musk GFY.
I think the technical term for what you propose is "a miracle."
If you keep slamming the stocks you are invested in, it is not a surprise. That is not in your best interest.
I get serious discussion of a company's strengths and weakness. Calling your investment shit on a regular basis seems more than a little counter productive.
But if whining publicly makes you feel better I guess you might as well, since I am told what is posted on message boards seems to have little effect on the share price
Be aware that the days listed in the EMA MAA schedule are not calendar days they are work days i.e. Monday thru Friday less holidays.
Good grief. I understand how to compute effect size etc. I also understand the consequences of high variability in scores resulting in a large standard deviation.
And there is a real possibility that a larger n in the placebo arm might have reduced the standard deviation and perhaps the mean.
Random selection has some issues especially when the n of the selected population is small. The smaller the n the likelihood that the selected population is less representative of the overall population. 30 is considered to be the smallest n that is normally used with the common statistical tools. An n less that 30 usually require the use of different tools.
There are both type 1 and type 2 errors.
Yes I understand that. As I said, I should have used absolute effect or, perhaps even better, the magnitude of change in the treatment arms.
I am posting on a message board not writing a scientific paper for publication.
Did I say that the difference between the drug response and the placebo didn't matter? I don't think so.
I was pointing out something else. You can agree with the point I was making or not as suits your fancy.
Frankly Scarlet...
Please reread my response.
Again, there is something inconsistent about your posting.
You seem to be be saying "I'll either lose big or win big." Do I have that right?
Yet your posting is 90% negative towards the company. Seems like you are rooting to lose big.
I did. I am discussing the absolute change in the treatment arm between 2-73 and Trofinetide.
Doc's discussion was about effect size in comparison to the placebo within each trial. Different things being discussed.
I probably should have used the words absolute effect size which would have been clearer.
If your cost basis is $4.01 sell now and take about a 50% profit. Most investors would be very pleased with that. After all if this is going to croak as you seem to expect you can buy back later if you change your mind about where Anavex is going.
There is something inconsistent about your posting.