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| Alias Born | 09/12/2017 |
Saturday, August 14, 2021 2:18:28 PM
I believe leronlimab is on clinical hold---
https://www.sec.gov/Archives/edgar/data/1175680/000000000021006508/filename1.pdf
Management will provide an update on ongoing work with the United States FDA and other regulatory agencies on using sub-population data to ensure future adequate trial design, in order to continue to further its clinical development of leronlimab in the treatment of patients with COVID-19. As indicated by the FDA and the Company previously, the CD12 trial did not meet mITT endpoints. The Company will provide further clarification on the secondary endpoints met in the critically ill pre-specified sub-population. As we continue to work with the FDA and other regulatory agencies, we ask investors to limit their outreach and respect the regulatory approval processes.
https://finance.yahoo.com/news/cytodyn-hold-webcast-may-18-234400533.html
https://www.sec.gov/Archives/edgar/data/1175680/000000000021006508/filename1.pdf
Management will provide an update on ongoing work with the United States FDA and other regulatory agencies on using sub-population data to ensure future adequate trial design, in order to continue to further its clinical development of leronlimab in the treatment of patients with COVID-19. As indicated by the FDA and the Company previously, the CD12 trial did not meet mITT endpoints. The Company will provide further clarification on the secondary endpoints met in the critically ill pre-specified sub-population. As we continue to work with the FDA and other regulatory agencies, we ask investors to limit their outreach and respect the regulatory approval processes.
https://finance.yahoo.com/news/cytodyn-hold-webcast-may-18-234400533.html
