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Thanks RedShoulder. God Bless and highest regards as you go through this journey with your wife.
Praying Blarcamesine gets into the hands of those who need asap.
Proving B's anti-fungal effectiveness is now in in-vivo study, so brick by brick. Looking forward to 2023.
It works wonders on A. fumigatus even improving corneal thickness per release.
"Brilacidin reduced fungal burden and disease severity, while also improving corneal thickness compared to control. Brilacidin-treated corneas harbored almost no viable fungus, suggesting the compound suppressed fungal proliferation within the cornea."
The surface of the front layer of the eye.
Brilacidin is over whelming.
"New in vivo data in an A. fumigatus murine fungal keratitis model showed Brilacidin reduced fungal burden and disease severity, while also improving corneal thickness compared to control. Brilacidin-treated corneas harbored almost no viable fungus, suggesting the compound suppressed fungal proliferation within the cornea. Worldwide, on an annual basis, fungal keratitis affects up to 1.5 million people, of whom 75 percent may lose an eye and/or their sight."
Study done on actual murine mouse corneas. Nice to see corneas improved after treatment with B. Huge news today.
Aspergillus fumigatus is on the WHO critical list. Great to see B working so well as an anti-fungal. Good deal. Time has come to partner.
It doesn't happen over night, 5years is a short time, first it's discovery and if lucky many trials. We saw 8+ then a take down. 30 bucks and another sell off. Sava ran to 130 I saw nobody complaining. That's what investors do you know bulls and bears. Who wants to run down a stock they actually own. Sell and move to greener pastures.
Funny how remdesiver fails it's first clinical trial and is then poo poo'd by the WHO and later becomes a covid-19 darling. Yes B showed strong anti-viral properties in pre-clinical studies also in the small subgroup sample those treated with B early from onset achieved sustained recovery more quickly.
"While the trial did not meet its primary endpoint in reducing time to sustained recovery through day 29, certain patient subgroups did show treatment benefits of Brilacidin for that primary endpoint. For example, patients treated early from onset of symptoms achieved sustained recovery more quickly (Brilacidin 5-dose group vs pooled placebo, p=0.03). To date, only a modicum of success has been demonstrated by any company conducting clinical trials in moderate-to-severe hospitalized cases of COVID-19. A possible reason for this may be owing to frequent changes in the standard of care with patients receiving a cocktail of fluctuating concomitant medications, which complicates the interpretation of the clinical trial data and that of the new drug candidate being evaluated. Clinical observations of COVID-19 patients treated with Brilacidin further lead us to believe that higher and more frequent dosing of Brilacidin may be more appropriate to tackle this complex disease in the hospital setting"
Clearly B needs more study and a human trial of early onset patients. That is what the nasally formula when completed will be tasked to do.
Yes, especially since Alzheimer's is a progressive disease. Any improvement from baseline is a wonderful outcome.
Reply from amstock82 posted on another board(investorvillage)- Updated - Re: Primary Endpoints Claims Trial Endpoints Not Met
The Primary endpoint of the ADAS Cog is first given this is the first thing analyzed by Anavex on the slide.
1) ADAS-Cog score change of or better -0.50 @ 48 weeks is defined as a clinically significant change. Therefore, patients with an improvement of -0.50 were defined as improved. (A later slide shows the improvement of -1.85 overall for all patients treated)
2) Among patients that improved with Anavex 2-73, the mean ADAS-Cog score improved -4.03.
They give the odds ratio for ITT or Intent-to-Treat population as 1.839. Basically, if an odds ratio is 1, then it is 50/50. 1.839 is 83.9% change of something. Or as they give it, people who got Anavex had an 83.9 or 84% more likely to improve compared to the placebo group.
The treatment group includes both the 30mg group and 50mg group as well as some of the patients who have the 20% chance of the altered gene (the gene that causes Anavex 2-73 to not work as well). And if the patient is already fairly far gone, they won't be able to measure improvements in the ADAS-Cog. They might see changes from MRI and other tools.
But given the -4.03 number, it means that the group of patients that improved - improved tremendously.
The p value is very good at 0.015. (the great p value is attributed to the large improvement and is unlikely to be random).
Next slide ADCS-ADL
This slide is analyzed the same way as the first ADAS-Cog.
The treatment group was 167% more likely to improve when compared to the placebo group with this test. This is very significant, and they also have a good p value of 0.0255.
Next slide. ANAVEX®2-73-AD-004 Primary Endpoint – ADAS-Cog
The raw data shows patients who took the placebo began with ADAS Cog of 29.18 (standard error of 0.61). For any one sample, the standard deviation can be large. (Standard deviation is a measure of the variability of single samples, while Standard Error is how much the population mean may differ from the sample mean.
The slide indicates that patients taking the placebo's scores in 48 weeks declined by 4.11 overall (SE=0.86).
The slide indicates that patients taking the 30 mg and 50 mg drug declined overall by 2.26 (SE=0.51).
At 48 weeks, they ended up with 161 patients for placebo and 301 in the treatment group. Inferred from slide 25 safety population of n=161 and n=301.
To do the t-test, use the following formula.
\begin{equation*}t=\dfrac{\bar{x}_{1}-\bar{x}_{2}}{\sqrt{(s^2(\frac{1}{n_{1}}+\frac{1}{n_{2}}))}}}\end{equation*}
There are a few potential ways to calculate this. That is because the baseline and placebo both have baseline measures and SE and then the SE changes at 48 weeks.
But to do it the easy way, go to the web tool that what's his name used and put in correct values and do the test for sample mean is greater than placebo/test mean.
(Thanks to the Evan Miller organization website test tool for t-test): https://www.evanmiller.org/ab-testing/t-test.html
(SE = Standard deviation / Square root of number of samples). Since we have SE and number of samples, it is easy to derive standard deviation to put into the tool from Evan Miller. Have to click in the Sample summary box to change the data. I.e., click in the round box next to the (Sample 1 Summary) and on the other side in the (Sample 2 Summary) to input data. Anavex also indicated on one of their slides the change in numbers due to deaths or dropouts in testing.
The p=0.0327 (Anavex has it at on their slide at p=0.033).
I also calculated the same thing using a more complex calculation which I won't go into, getting the t value, degrees of freedom and comparing it to the chart: https://cdn.scribbr.com/wp-content/uploads/2022/06/Students-t-table-one-tailed-two-tailed-L-Scribbr.pdf
It comes up to approximately the same.
The trick short traders played is mostly to not use the correct comparison with the tool. (That is why the person who posted a picture from the Evan Miller Organization cut off part of the results from his picture). What we want to determine is if there is a difference in the 'means' that is statistically significant? In other words, could the change in means be random chance or is it real? Second, he didn't put in the right values but that would only have had a minor impact.
Note, some may say that the company didn't point out what type of t-test that they are using. They don't have to do so because to anyone who has knowledge of statistics, the right methodology is apparent based on what they are testing for. In other words, all they have to do is know that they are trying to prove that the use of Anavex 2-73 improves cognitive decline. Based on what they are trying to prove, that determines what test to use. The slide indicates:
"ANAVEX®2-73 treatment slowed cognitive decline by 45% compared to placebo at 48 weeks"
The test is to show whether or not the above claim is true. It is determined to be true if the test results in p < 0.05. I did the calculation 3 ways one of which was using Evan Miller's tool. Sample 1 using his tool is the placebo data. Sample 2 is Anavex 2-73. The Evan Miller tool shows that Sample 1 mean is greater with p value better than 0.05 and an actual p value of p=0.0327. Since Sample 1 mean is greater, this indicates that Anavex 2-73 slowed cognitive decline with a certainty of p=0.0327. The 45% can be calculated as given on the slide.
The other two ways I calculated t values came out to approximately the same conclusion with ~ p=0.03. The reason I calculated it manually is to verify the Evan Miller organization tool and the overall methodology.
NOTE: Some say that the FDA indicates a t-test two tailed test must be used and a one tail test is not the norm. This is BS. The statistical test used is based on what they are trying to show. Based on what is being proved by Anavex, the test is determined to be a t-test two sample test.
They got what they wanted.
"We are short" No surprise.lol
The company's under attack because the data is that good. No reason to sic the dogs otherwise.
Somebody's buying them up that's for sure. Way to many for retail to handle.
Notice the constant reference of lawsuit. Enough said. Dr Missling has the data and repeated primary and secondary endpoints were met.
From the conference call-
ADAS-Cog - meaningful improvement in cognition
ADCS-ADL- meaningful improvement in function
A-273 was reported safe.
Agree. This could cause a monumental monetary shift in treating Alzheimer's. The word will ultimately get out, people and caregivers will want it. Change will come.
ADAS-Cog scores meaningful improvement in cognition
ADCS-ADL scores meaningful improvement in function
So yes people improved.
A-273 was reported safe.
Blarcamesine now!
I think an important note to Dr Missling et al is that A-273, if approved, the cost would not be shifted to medicare because as a pill it would be covered under ones drug plan. Due to Lecanemab being an infusion plus the associated outpatient costs it was put under medicare billing which set in premium increases for all those on medicare.
Short fodder. I'm buying and holding strong.
Top line results put shorts in a jam but good.
All those in the ABSSSI trial who received B got a single dose infusion and went home healed of their affliction. Dapto takes 7 infusions. Also there's the likelihood that B's MOA will not create bacterial resistance. Looking for further anti-fungal reporting plus a nasal formula update.
Thank you! Much appreciated.
Me too as they say. I see this as a great opportunity. We have been de risked since the last time we were at these levels.
Dr Missling is a competent CEO and with the excellent results as what we have (by his leadership I may add) can get A-273 approved for Alzheimer, PDD, Retts, FragileX. So far so good. BP value will likely be effected when approval comes but the plus side and what's important is people are helped:)
Ah gotcha yes a bedtime dosing.
I heard it as SAP statistical analysis protocol. My take is they followed the planned test study and found A-273 checked all the boxes. Starts@44:35 Got to listen carefully though.
https://video.wixstatic.com/video/79bcf7_6566f1d485d2424eadf745c64a05ff7a/480p/mp4/file.mp4
Good post! This is where the rubber meets the road. A very real threat in BP's future value. We get excellent trial results and it's an all out effort to tank the company. Hoping for some honest analysts.
Yes BP's definitely know now. We have a lot of new bears here. Biogen got bested good.
We were just handed superior Alzheimer's results with more indications to come. I consider this a long term buy and hold. I've been adding again as of late.
Anavex will likely take market share of other companies in this space and that's a rub. My take away this morning is if your marketing an infusion drug your in trouble.
That was bad. Hopefully he is still well. The elderly are precious to their families.
I imagine reading a book, playing piano and painting. Dr Missling can likely give more in-depth report now that trial has finished. I hope A-273 gives a lot of people long term healing. Good stuff.
Exactly, here's what they all saw and it's as crisp and clear as a cold December morning. Huge news.
ANAVEX®2-73 (BLARCAMESINE) PHASE 2B/3 STUDY MET PRIMARY AND KEY SECONDARY ENDPOINTS,
SHOWING STATISTICALLY SIGNIFICANT REDUCTION OF CLINICAL DECLINE IN GLOBAL CLINICAL STUDY OF PATIENTS WITH EARLY ALZHEIMER’S DISEASE
Yeah just look at donepizil. Early approval.
We have a winner!! A-273 may just set the new standard of care.
I believe they are afraid of a cure as funding would dwindle. Anavex as we have seen has some uphill to go but positive news trumps all. Big organizational donors get all the accolades.
Alzheimer's is a very hard nut to crack so I'll go out on a limb and say longs are quite pleased with results. That's really all that matters.
Your trying too hard. Trial was and is very successful against a really tough disease. Read the 8k.