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I see you are a professional. You have to excuse me but it would take me some time to get trained in the arcana of statistics to understand that. I just found the simples solution and run with it. I guess for those who know I seem ignorant and ridiculous. On the other hand it is good that Anavex uses much more sophisticated tools than I would conceive.
Thank you for explaining this to me. I am a layman, my understanding is limited. All can do is to read you sources and update my post. That was the simplest explanation as I was ignorant of those you pointed out. Thank you. I bet your a health professional. Are you?
Sorry for that but I just managed to set up paid option and don’t know how override it. Just check it again I will post 4 times a month. It just costs a lot of time. Regarding the post, it seems there a great reduction of loss of brain volume, it just amazing. Of course, it is arithmetics but very compelling
Thank you. If you would like, check my other content. Just a cup of tea.
I and Max Hitek we wrote a new post on my blog regarding a paper about Rett syndrome trials. There is a narrative on the paper and some calculations. see the post Rett and Area Under The Curve Expalnation
A simple way to calculate threshold for p-value < .05 is to get standard error which placebo arm standard deviation divided by square root of n. To have small p-value you want you want small standard deviation and large n. Once you get SE you multiply it by 1.97 then add it the mean of placebo. If mean of dosed is farther away from mean+1.97*SE the p-value is smaller than .05. So as you see smaller than .05 could be materially better than .05. If you set SD and n as set then difference between means has to be a bit larger. An idea for post.
Here again mathematics and nature of the disease come into play. It’s not that important what you see in the graph as you need to know what was the baseline deteriorating when trial started. Paper analyzing data collected by ADNI project (consortium of big pharma testing for the disease) identified that the rate of decline varied with the severity of decline of patients- proportional and inversly proportional to age, 22% greater with APOE 4 and 10% greater for women. So you dosed cohort experiences deterioration due natural course of the disease and therapeutic effect of drug at the same time. If therapeutic effect overpowers natural course of disease we have higher cognition scores. $SAVA looks at cognition scores but has baseline of 11 ADAS-Cog compared to baseline ADAs-Cog scores of 30 for AVXL. This can be parlayed in into deterioration scores of respectively .9 and 4.8. So $AVXL has to “fight the disease” 5 times more than $SAVA drug which seems to fall into the donepezil trap of helping and then declining. My only fault is that I too quickly compared it to leqembi whereas it is more like Donezepil.
Let’s get into the way statistical significance is calculated. Calculation of the 5% threshold. You take the standard deviation of placebo and decide by square root of number of patients and you get so called standard error. Now you multiply standard error by number 2 or 1.96 (I don’t remember which) and you get a number below or above which must be mean of dosed cohort to be less then .05 probability of a fluke. So if you expect standard deviation to be similar more or less in both trials and greatest variation is in the mean of dosed it leaves the n to be the most controlled number. That is why with a very large sample of patients lower efficacy suffices to achieve statistically significant. To get a ratio divide square root of $Sava cohort n by square root of $AVXL n.
I will have a post comparing results from my take on phase 2b/3 and Simufilam in few days. If Anavex reached statistically significant with 509 patients and phase 3 for Simufilam uses 1800 than assuming Simufilam reaches statistical significance the Simufilam efficacy is much lower. Crudely by half. All to reach statistical significance. There is some efficacy but not much. Read my second latest post on AVXL phase 2b/3. The conclusion is that cognitive testing has a ceiling since the nature of AD at this stage precludes fully reversing the disease.
A bit of clickbait. On the other hand that is extreme as they select to prove efficacy those whose baseline was so low that in is six months those not dosed did not even deteriorated. This defeats the essence of cognitive testing and is laughable to the people like me.
I have new post on my blog piotrpeterblog.com Why you won't see the full phase 2b/3 data any time soon. If you are also involved with $SAVA read this SAVA has reached the extreme in pursuit of efficacy
pietrzkiewicz@mac.com
Post on my blog discussing the results of Phase2b/3 Post on Phase2b/3 Results
If I am right in my analysis the 50mg cohort is worth is weight in gold.
I did not post here for quite some time. Here is a link to my newest post.
piotrpeterblog.com
How Sauna frequent users have a lower incidence of dementia and how this squares with the benefits of Blarcamesine. See my blog
https://piotrpeterblog.com/2022/05/12/that-little-cell-stress-that-does-it-or-right-chaperone-protein-for-right-misfolded-protein-in-alzheimers-and-parkinsons-avxl-blarcamesine/
New Post on My Blog. Study on Parkinson's looks into Mitochodrial health. Blarcamesine has been there for years. Now, is the vindication.
blog post
Short Note on PDD results. Part III and Part IV suggest that motor neurons are recovering with Blacamesine.
See my blog. blog post on PDD results
I reversed calculated RSBQ scores for Rett Syndrome AVTAR RS-002 from RSBQ-ACU Cohen'd value and the information released by Dr Missling. Read my new post
https://piotrpeterblog.com/2022/02/10/comparing-trofinetide-and-anavex2-73-this-installment-we-try-to-estimated-rsbq-score-of-avatar-rs-002-from-hearsay-and-formulas-for-cohens-d-for-rsbq-acu-all-for-rett-syndrome-winning-drug-avxl/
New post on my blog. I turned the RSBQ Trofinetide scores into RSBQ-ACU, a bit fudging. many complained that they lost their sense of grounding of the results given in a new score type. So many saw this as the case of oranges and apples. I turned the data into one format and made some guesstimates.
https://piotrpeterblog.com/2022/02/09/rsbq-auc-a-more-sensitive-measure-of-rett-syndrome-data-now-applied-to-acad-trofinetide-ready-comparison-to-avxl-anavex2-73/
I realize that everybody wants certainty and fast food like delivery but life is what it is. Don’t look at the share price because you get discouraged and disappointed. Instead look at results. There 3 cases for biotech. 1) SP reflects the drug. 2) SP does not reflect drug but SP is initially high on hopes of never materialized payout or 3) SP lags the payout.
I have see SP reaching high and then collapsing on news.
I bought some options today, so I put money where my mouth is.
I am right now looking through $ACAD data and I see a different pattern then $AVXL data.
I will not debate you on FDA phase 3 change or area under the curve transformation. You take my word for or leave at that. These are facts to interpreted but one fact is obvious. Anavex2-73 beats trofinetide hands down. It did in RS-001 and in RS-002 it even improved the score. It would be strange if FDA would not welcome it.
Let’s say Dr M does it himself on the clinical trials webpage. What Bureaucrats in FDA would think about it? Just offend them and you wrestle with a pig in its element the mud. No sane CEO of small biotech would do it, especially Dr M.
New Post on my blog soemthing about p-value calculations and effect size for AVATAR RS-002 Rett Syndrome
Blog Post
I have just written a short analysis of RS-002 results with explanations. see my blog.
Piotrpeterblog.com FDA Made $AVXL....
New post on my blog Transcription or Translation: Two Sides of Blarcamesine, Rett Syndrome
Please, post this on Facebook as I quit Facebook
Just finished writing about Blarcamesine and Bryostatine. There might be a connection between them. Also, I made a certain distinction between "preventatives" and "regenerative" with Blarcamesine straddling both.
Blog Post about neurotrophic factors
$AVXL Phase2a data vs. $SAVA 9 months
new post
We have to ask ourself a question. Is all about simufilam or about defense of Aduhelm? I have no subscription and don’t intend to spent the money. What I gather from the language used this is mostly ad hominem like “undergrad”. From the top data you can’t tell that. Are they in possession of individual patient data? because only then you can say those things. The individual patients data went through statistical grinder and is like a sausage. You don’t see the separate ingredients.
On the other hand, the reputation of the CEO does not engender confidence.
Simufilam is indeed a serious contender to Aduhelm and people like AF need to put food on the on the table. P just saying
SAVA results will be measured vs. expectations and these are just “no more deterioration, please!”. So the hurdle is not set very high. I bet SAVA gets over this and soars on false pretenses that it made a medical history event. Besides everybody is enamored with its 50 patients in the first interim phase 2b read out. I might be right maybe at first but in few months $ANVS reads its 40 people cohort on Parkinson’s, Q4 2021 has CRTX reading its phase 3. How $SAVA survive this I don’t know? For us the only competition right now is $CRTX. $ANVS is a distant one so is $SYnaptogenix and $ATHA which reads phase 2 Q4 2021 or Q12022 which can turn it into serious competition.
Thank you for acknowledging my efforts.
A new post in my blog Blog
The SAVA CEO decided go for all or nothing as he needs the market cap to go over $5bln to collect big cash award. Somebody already did dd on this. ANVS on the other hand most likely will be sold soon.
Dr Missling released numbers for some “select patients” referring to phase 2a. Since this was kind of out of context who exactly those “select patients” and that number were incongruent with what was released before I concluded that it was a hidden message about the phase 2b/3. If so than @52 week ADAS-Cog could be -4.7 and @ 70 weeks -6.99, as far as I remember. Starting with ADAS-Cog +15 or + 18 that is great difference. But as I said that is just my suspicion because the pr was kind of strange and odd.
I think that after AAIC money will flow from $SAVA to $ANVS. $SAVA works on a sideshow in AD. The results can be middling vs. ,comparable to $AVXL, by $ANVS. There are some hints in the 28 day data that $CRTX might have very similar results to $ANVS. $CRTX Achilles heel is undisclosed liver problem which is supposed to to dissipate without harm, according to co. Yet, FDA had to put partial clinical hold on OLE on Phase 3. Results due in Q4 2021. I would not be surprised if $SAVA would falter, money would flow to $ANVS, and the maybe $CRTX after results. $AVXL is the ugly duckling. I suspect that the results from phase 2b/3 might be in line with presented in latest release on “select patients” that is MMSE +2 at 52w and +3 @70 weeks. When compared with ADAS-Cog -18 for mean that is almost 7+7 point oh sh*t I mixed up + with -! $AVXL has not been left for the retail to chase. So it highly unpredictable
These patient are Mild Cognitive Impairment but they all have to have amyloid plaque already. I think if you look up the clinicaltrials.gov you will find it in the spec.
AAIC 2021 data dump $SAVA $ANVS and $AVXL. A frame of reference to sort the data.
Blog Post
Great Find.
None of these is anti-aging or general drug after the paper in PR. Inkling of that I pick up in the implications of data on Phase2a drop out. See few recent blog posts. Piotrpeterblog.com
So now anybody over 50 (?) is population with intent to treat (ITT). The other two don’t even come up close.