Replies to post #149609 on Cytodyn Inc (CYDY)

[SF Anony]

Thank you for that exhaustive and extensively cited information, CTMedic. I find myself hoping that’s one of the last comprehensive posts that need to be made before an announcement states everything you’ve documented there in a different form:

Revenue from the sale of Virologix.

[tradero]

One of the best posts I have read here. Thank you CTMedic

[C-20]

CTMedic - wow ! Great post and very well stated and statistically backed.

[tikotiko]

Post of the week, thanks!
In my book, it deserves a sticky from the Mods!

[lostmyballs]

I believe ((( them are the facts))

[BostonSportsNut]

Broke The Internet. Well done.

[EponymousKook]

This post needs to be stickied.

[Mohave]

Hey CT, maybe you should send your post to the FDA to remind them and then ask them what the hold-up is...lol!

[mldillon]

I have been following this company for a year and I am heavily invested. I have enjoyed your posts immensely. This is a nice summary and the reason I am still in it. Along with Rocleo, Misu, Breeze and others I think this must be at least successful. It willet at least EUA.

Some with a great knowledge of statistics have considered it worthless. The survival rates for LL would have to be phenomenal to reach statistic significance by a summary of >100 studies showing placebo mortality in low 20's, but that didn't ever mention the Aviptadil placebo group mortality of 30% and the Relief Therapeutics study mortality of 33% in placebo.

Perhaps the most important thing is that statistical significance is not the only parameter of importance in gaining approval for this treatment. Statistical significance is not clinical significance. Perhaps in this pandemic the FDA is becoming more aware of that fact. The Remdeathisnear achieved some kind of significance that lead to EUA, but we know it is not clinically significant for survival. The changing SOC and the relatively small trail size may not reach Statistical significance with the majority of patients being enrolled after mid November, but it will reach clinical significance - it already has as the anecdotal reports testify to. I think that Dr Woodstock has alluded to the consideration of clinical significance in the latest release on MAB's.

Finally, there is some desire in science and medicine to do away with the p-value metric.
see here: https://jim.bmj.com/content/64/7/1166

excerpt:

Take-home points for using probability values in clinical research
Assuming no association exists, a test statistic determines a p value for (ie, the tail probability of) an observed result, or a more extreme result, occurring by random chance.

The threshold p value of ≤0.05 for statistical significance, promoted in the early 20th century only as an informal suggestion, indicates a 1-in-20 chance of a false-positive inference (ie, assuming an exposure–outcome association when it does not exist).

Even if a study is conducted impeccably and reported accurately, clinicians and investigators should not assume that p≤0.05 implies a ‘true’ association—and comparing a p value to a threshold does not represent a win–lose situation.

In genomic studies, p value thresholds such as 5×10-8 reflect the extremely large number of associations (eg, alleles) being evaluated for each participant.

In addition to p values, or CIs (as another format for expressing stability of results), a numerical result for the strength of an association (eg, relative risk) is essential information.

Rigorous statistical analyses should be combined with relevant clinical insight regarding the corresponding research question, data collection, and study design.

While considering the conceptual issues of validity and generalizability, interpreting the numerical results of clinical research investigations should assess the strength of association, magnitude of p values, CIs, and sample size.

and here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7064671/

excerpt:

In 2016, the American Statistical Association (ASA) released a statement warning against the misuse of statistical significance and p values [5]. A special issue in The American Statistician [5] presented 37 papers on “Statistical inference in the 21st century: a world beyond p < 0.05”.

The main ASA points are highlighted in the form of do nots, as follows:

Do not base your conclusions solely on whether an association or effect was found to be statistically significant (i.e., the p value passed some arbitrary threshold such as p < 0.05);

Do not believe that an association or effect exists just because it was statistically significant;

Do not believe that an association or effect is absent just because it was not statistically significant;

Do not believe that your p value gives the probability that chance alone produced the observed association or effect or the probability that your test hypothesis is true;

Do not conclude anything about scientific or practical importance based on statistical significance (or lack thereof).

If you read the points excerpted above, or better the papers, you will see that statics alone do not tell the value of this drug. I believe the clinical reports and as an emergency physician, I hope to God that we get to use this medicine widely in the US and throughout the world. Maybe Woodcock's revised guidelines in the face of Covid variants reflects a desire to employ clinical significance into some degree n drug approval - I really hope so. I also hope that the FDA will not strong-arm CytoDyn into some decremental association with another drug or company.

GLTUA

[Easka]

CT Thanks for work. Excellent post.