Sunday, November 07, 2021 10:26:23 PM
CROs (Contract Research Organization) are contracted, in this case, so a small biotech like CytoDyn doesn't have to maintain a large staff to run trials in-house from conception to approval.
Yes, CytoDyn has had Chief Medical Officers and other members of the management team that will play a role but, trials are "farmed out: to the CRO on a contractual basis to essentially cover every aspect of the trial. It appears (and I'm sure we'll find out more) CytoDyn was relying on the self-proclaimed expertise of Amarex to get their trials from conception to approval - except we've gotten no approvals. Amarex has some ownership of the design flaws, data problems, and reporting problems (BLA) we've seen with many of the trials. They brag about their successes:
Years
20+ Years
Trials
400+ Trials
Patients
85000+ Patients
Ide
125+ IND/IDE/510(k)s
Approvals
25 Approvals
***
I guess the results resulting from Amarex's work on behalf of CytoDyn won't be part of Amarex's advertising campaign.
IMO
Yes, CytoDyn has had Chief Medical Officers and other members of the management team that will play a role but, trials are "farmed out: to the CRO on a contractual basis to essentially cover every aspect of the trial. It appears (and I'm sure we'll find out more) CytoDyn was relying on the self-proclaimed expertise of Amarex to get their trials from conception to approval - except we've gotten no approvals. Amarex has some ownership of the design flaws, data problems, and reporting problems (BLA) we've seen with many of the trials. They brag about their successes:
Years
20+ Years
Trials
400+ Trials
Patients
85000+ Patients
Ide
125+ IND/IDE/510(k)s
Approvals
25 Approvals
***
I guess the results resulting from Amarex's work on behalf of CytoDyn won't be part of Amarex's advertising campaign.
IMO
Recent CYDY News
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/21/2026 04:15:12 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/20/2026 09:08:39 PM
- CytoDyn to Present at the LD Micro Invitational XVI • GlobeNewswire Inc. • 05/15/2026 12:30:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • InvestorsHub NewsWire • 05/11/2026 01:00:00 PM
- CNS Drug Delivery Breakthroughs Unlock Significant Biotech Market Opportunities • GlobeNewswire Inc. • 05/11/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/30/2026 08:32:50 PM
- 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
