Wednesday, September 23, 2020 5:20:12 AM
Midnight-Rider..Interesting question..How should we do the Long Hauler Trial..??
BY NOT REINVENTING THE WHEEL...
We have a Group of 86 Mild to Moderate...AND...195 Severe to Critical patients who have received Leronlimab..OR..a placebo in the last 5 months.. !!!
Take a look at the Primary and Secondary End points..in OUR protocol to be submitted to the FDA ..next week..for the Long Hauler Trial we’ve requested..!!!
Make a Questionnaire of these 15-16 symptoms..Have Grip it and Rip it do something useful..For a change..!!! Have him do a telephonic interview with these 86 + 195 = 281 patient’s.. in a blinded fashion..Where he is NOT aware of who got Leronlimab and who the placebo..
Tabulate the responses..!!!
This MAY give us a Treasure Trove of information..Shortness of Breath..Brain Fog..Fatigue..Myalgias..May disproportionately be improved in Leronlimab receiving patient’s.. MAKE THESE THE PRIMARY END POINTS..!!!
We may be interested in Post Covid Strokes..BUT .. if you cannot get to a Statistically Significant Level..Because there are NOT ENOUGH STROKES in a small population of Long Haulers..Make Strokes a Secondary End Point..Not a Primary One.. !!!
Rushing into a Long Hauler Trial ..To determine what symptoms we can treat.. MAKES NO SENSE..When we have these 281 patient’s..who can guide us..!!!
IMHO..
BY NOT REINVENTING THE WHEEL...
We have a Group of 86 Mild to Moderate...AND...195 Severe to Critical patients who have received Leronlimab..OR..a placebo in the last 5 months.. !!!
Take a look at the Primary and Secondary End points..in OUR protocol to be submitted to the FDA ..next week..for the Long Hauler Trial we’ve requested..!!!
Make a Questionnaire of these 15-16 symptoms..Have Grip it and Rip it do something useful..For a change..!!! Have him do a telephonic interview with these 86 + 195 = 281 patient’s.. in a blinded fashion..Where he is NOT aware of who got Leronlimab and who the placebo..
Tabulate the responses..!!!
This MAY give us a Treasure Trove of information..Shortness of Breath..Brain Fog..Fatigue..Myalgias..May disproportionately be improved in Leronlimab receiving patient’s.. MAKE THESE THE PRIMARY END POINTS..!!!
We may be interested in Post Covid Strokes..BUT .. if you cannot get to a Statistically Significant Level..Because there are NOT ENOUGH STROKES in a small population of Long Haulers..Make Strokes a Secondary End Point..Not a Primary One.. !!!
Rushing into a Long Hauler Trial ..To determine what symptoms we can treat.. MAKES NO SENSE..When we have these 281 patient’s..who can guide us..!!!
IMHO..
Recent CYDY News
- CytoDyn Announces First Patient Dosed in Expanded Access Program for Leronlimab in Triple-Negative Breast Cancer • GlobeNewswire Inc. • 04/27/2026 12:30:00 PM
- CytoDyn to Host Investor Webcast • GlobeNewswire Inc. • 04/23/2026 12:30:00 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 04/22/2026 09:21:50 PM
- CytoDyn Presents New Leronlimab Data in Metastatic Colorectal Cancer at AACR Annual Meeting 2026 • GlobeNewswire Inc. • 04/22/2026 12:30:00 PM
- CytoDyn Completes Enrollment in Phase 2 Metastatic Colorectal Cancer Study • GlobeNewswire Inc. • 04/21/2026 08:10:00 PM
- CytoDyn Presents New Leronlimab Data in Metastatic Triple-Negative Breast Cancer at AACR Annual Meeting 2026 • GlobeNewswire Inc. • 04/20/2026 12:30:00 PM
- CytoDyn to Present at the AACR Annual Meeting 2026 • GlobeNewswire Inc. • 04/14/2026 12:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 04/08/2026 09:15:18 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 04/08/2026 12:30:28 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/25/2026 09:16:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:24:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:23:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:22:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:21:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:20:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/24/2026 09:20:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/24/2026 09:15:24 PM
- CytoDyn Presents at AACR Special Conference in Cancer Research: Brain Cancer • GlobeNewswire Inc. • 03/24/2026 12:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/09/2026 09:15:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/05/2026 01:35:02 PM
- CytoDyn Closes $17.5 Million Financing to Fund Continued Development of Leronlimab • GlobeNewswire Inc. • 03/05/2026 01:30:00 PM
- CytoDyn Presents Novel CCR5 Inhibition Mechanisms and Long-Term Survival Signals for Leronlimab in Metastatic Breast Cancer at AACR Immuno-Oncology Conference • GlobeNewswire Inc. • 02/20/2026 01:30:00 PM
- CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer • GlobeNewswire Inc. • 01/27/2026 01:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/09/2026 10:15:22 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 01/09/2026 01:30:45 PM
