Wednesday, March 03, 2021 3:26:21 AM
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
Recent CYDY News
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 10/01/2024 09:15:42 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 09/30/2024 09:01:16 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/13/2024 04:15:06 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 09/07/2024 12:44:56 AM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 09/07/2024 12:42:22 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 08/15/2024 09:21:30 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/22/2024 01:00:58 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:17:48 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:16:28 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/09/2024 09:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 12:46:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
- Form SC TO-I - Tender offer statement by Issuer • Edgar (US Regulatory) • 06/03/2024 09:10:56 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:09:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/09/2024 02:30:20 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:15:34 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 02:00:24 AM
North Bay Resources Announces Assays up to 5 oz/ton Gold, 1.5 oz/ton Platinum, 0.5 oz/ton Palladium, and 0.5 oz/ton Rhodium at Mt. Vernon Gold Mine, Sierra County, California • NBRI • Oct 4, 2024 9:15 AM
Basanite, Inc. Appoints Ali Manav as Interim Chief Executive Officer • BASA • Oct 3, 2024 9:15 AM
Integrated Ventures Announces Launch of MedWell Facilities, LLC and Lease Agreement with Giant Fitness Clubs • INTV • Oct 3, 2024 8:45 AM
Beyond the Horizon: Innovative Drug Combinations Offer New Hope for Alzheimer's and More • NVS • Oct 3, 2024 8:45 AM
SMX and FinGo Enter Into Collaboration Mandate to Develop a Joint 'Physical to Digital' Platform Service To Enhance Natural Rubber Industry's Ability to Report on Sustainable and Ethical Supply Chains • SMX • Oct 3, 2024 7:00 AM
Transforming Alzheimer's Treatment: Innovative Combinations to Boost Cognition • PFE • Oct 2, 2024 9:00 AM