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What is the difference between the mabs and Blarcamesine?
The mabs have been approved by the FDA.
Sufficiently tight prescreening becomes precision medicine. That should be reflected in the authorization literature as a restriction in prescribing.
Why should the SEC do anything but wait to see how the discovery for this case goes? NWBO will be doing a lot of work that will benefit the SEC if and when it decides to start an investigation. SEC has limited resources so letting NWBO do much of the heavy lifting makes good sense.
Besides if NWBO wins the case, the penalties are likely to be much higher than if the SEC was to investigate and settle a case. If the SEC finds criminal wrong doing all it can do is refer the case to the DOJ.
In the case of the Anavex OLE it can be used for more than the safety and efficacy data. The OLE provides an opportunity to trial the slower titration and night time drug administration. The placebo arm provides a 2-73 naïve group of subjects to see what effect those changes will make.
The pool of subjects is self selected and is made up of just the placebo subjects that made it through the entire trial protocol so it is not as representative a population as the placebo arm was at the beginning of the trial. So in weakens the strength of results and they will not be considered as strong as they would be if those changes had been made at the beginning of the trial.
Having said that, if there are improvements in the drop out rate that will be considered instructive.
Probably not. You would run into rejection issues because the cells would not be from the same person. Similar to transplant rejection. Histocompatibility.
That is called wishful thinking.
Because a number of the index funds publish the rules that they use to constitute their indexes and those are executed at the "numeric level".
If this information is correct then it would seems that the tutes are buy discretionary shares.
Q3 23 the share price ranged $5.14 to $9.58
Q1 24 ranged from $5.90 to$5.02.
So that suggests that the increase in shares was not due to index funds having to buy more due to increased cap weighting.
Not at all surprising that most shares held by institutions are in index funds.
Let's see.
Under $5 share price limits many institutions.
No revenues.
Not a proven MOA.
MOA is way outside of the mainstream.
Primarily in the AD space which is VERY HIGH RISK.
Developmental bio tech which is a small sector so many institutions are not interested.
A year or more away from a drug approval.
That there is any discretionary institutional holding is more interesting.
Gosh, I guess the many thousands of shares I have in a Vanguard account don't count.
Although, I can't claim any part of the Vanguard increase since I haven't bought any additional AVXL in that account in 2 years.
That is why I asked the question. I might learn something from his answer.
Interesting that you have been holding Anavex for just under ten years and just under a year ago you joined Ihub. What were your sources of information for those other 9 years?
The 20 completers were out of a population of 30 for the OLE.
The OLE data would not likely be involved in a paper about the original trial.
What are the criteria for a re-listing?
It says completed on Clinicaltrials.gov.
What is it that you are wanting?
As you pointed out, those that dropped out were not eligible for the OLE. 96% of eligible choose to continue. That includes those in the placebo arm which knew that they had not received the drug and decided they wanted to try it..
You are certainly right about the survival of NWBO. It is an amazing story.
We shall see how this turns out. If they can up list with out an RS I'll be the first to congratulate them for another amazing feat.
You are quite correct. NWBO has fewer shares outstanding than the BP companies you list. What you didn't list is the revenues of those companies and the earnings per share. That is the difference.
NWBO doesn't make any profits and has minimal revenues. It is not even an apples and oranges comparison, it's more like a Wright flyer and Boeing 747 comparison.
Say what you will, but most of the time when more information is released the share price drops. Even when the news is good.
I sure hope that the peer reviewed paper is worth the wait.
Latest filing show 84,795,xxx shares. Not real close to "that 2nd 100M shares".
I agree that many times an RS doesn't work out well. Usually that is because a company has little to no income and no real hope of immediate revenue stream. It is a desperate attempt to keep the doors open with little hope for the future and frequently involves vulture financing.
On those occasions where an RS does work it is usually for an up list and the company is looking at an increasing revenue stream. I think that is the case with a NWBO RS. The up list enables a growing company to access funding on reasonable terms that other wise would not be available.
I am not advocating for an RS. I am pointing out that an up list with this many shares is more difficult.
In general terms, most exchanges don't like to see that many shares OS. For one reason it makes it hard to get the share price up above the $5 range. Most exchanges would like the SP to be much higher than that. Having such a large OS makes it harder for the SP to go up.
Also the large number of shares makes the statistics look weak. PE ratio, earnings per share etc.
I can't see an up list with the OS being as large as it is. I would expect a reverse split prior to an up list.
If the share price can hold after the up list it wouldn't hurt share holders and could pave the way for future SP appreciation.
I guess we will let the CHMP decide how doubtful the results are.
The results do not have to the best thing since sliced bread, they just have to be better than the current SOC. Given that the EMA has given the Mabs a thumbs down, the current SOC is a very low bar.
I agree that the data we have seen so far is not the overwhelming success we'd like to see. However it is worth remembering that there is a lot of data that we have not seen.
Not necessarily. Both arms were concerned about Covid. The treatment arm had some symptoms that the placebo arm did not. Those symptoms did not have to rise to the level of an adverse event to amplify the heightened awareness created by the concern over catching Covid.
A slight nudge of very mild side effect combined with Covid paranoia could easily take someone over the tipping point and lead to withdrawl.
Neither. It's a semi-clever way to poke at people that hold a view different from his own. Similar to the WGT pokes we see on the board.
Just people that have a different opinion than you. It turns out that it is ok to view the same information and come to different conclusions.
Why do you care what my thoughts about the SP come Christmas? They have no effect on anyone else but me.
I'm seeing them come and go with no obvious pattern.
Me?
I like this stock. My cost basis is well below the current SP. I follow the day to day price only because I have some shares I use for trading. If it weren't for those I would not pay attention to the day to day SP and wait for the approvals before paying close attention.
And yet you are still in it.
If you think that getting AD approved by the FDA is lower probability why would you expect Anavex to go there first?
Getting approval by the EMA first has several advantages. One, it sets a precedent. Two, it gives Anavex insight into what questions regulators might have about the AD submission so the company can address those prior to the NDA submission. Three, most of the MAA can be directly repurposed into the NDA lowering the costs of submission.
Given the difference in processing times between the EMA and the FDA, it would seem likely that they will be decided upon about the same time,. That would increase Anavex's leverage in partnering negotiations.
You may remember that there is an ongoing law suit against Anavex at the moment. Seems that taking advantage of forward looking statement protections is a wise choice. Or maybe you would like to see Missling stick his neck out unnecessarily. Are lawsuits your friend?
What a silly statement. Apparently you have neglected the timeline involved in those revenue projections. SMH.
I suspect all of that would be in the labeling. I get similar instructions on drugs such as take with food, take on an empty stomach, take in the morning etc.
That long meaning 15 years.
Nor should they. The situation hasn't changed. Anavex is a developmental biotech pursuing a novel approach to treating a disease that major BPs have spent many billions of Dollars on in research and still haven't come up with a successful treatment.
The history of AD potential treatments is one of consistent failure.
So until Anavex can conclusively demonstrate that its completely new approach works, most big money will watch and not invest.
EMU approval for AD will legitimize the approach Anavex has taken and the big money will show up. Till then, Anavex is at the mercy of shorts, momo traders, and other opportunists of the stock market. What many here believe is Anavex's intrinsic value has little to do with the share price.
Some segments are more corrupt than others. Developmental biotech segment is subject to more manipulation for all the reasons that Investor just gave.
With that said, there are still opportunities in bio tech to make very serious money. That is why most people on the board describe bio tech as high risk and high reward.
Biotech can go from $1 to $150 or from $20 to $1.50. The volatility is attractive to many.
US patents are 20 years from earliest application.
Besides, I don't think that 2-73 will be on the market that long. Once the MOA is convincingly established other companies will be working on new drugs and approaches for the S1 system. Just like there is a chance that 3-71 might replace 2-73.
You do realize that the people that are/can/might manipulate the share price take pains to not leave tracks since that is a crime.
Even so, if you looked at the list of SEC enforcement actions I recently posted for 2023, you will see that such manipulation does exist and sometimes people/companies get caught doing it and the SEC takes action.