regulatory
confidence high
sentiment neutral
materiality 0.70
CytoDyn: FDA lifts partial clinical hold, imposes new full hold on revised protocol; expects January 2024 submission
CytoDyn Inc.
- Partial clinical hold from March 2022 lifted by FDA in December 2023.
- New full clinical hold placed on proposed HIV trial protocol submitted November 2023.
- Company to incorporate FDA feedback and submit amended protocol by January 2024.
- Views partial hold resolution as significant step; full hold expected resolved after response.
- Proposed HIV study aims to establish leronlimab's mechanism of action cost-effectively.