Key FDA Oncology Initiatives: Project Optimus: A
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Posted On: 06/24/2025 8:23:54 PM
Key FDA Oncology Initiatives:
Project Optimus:
Aims to reform the dose optimization and dose selection paradigm in oncology drug development, moving away from the current model based on cytotoxic chemotherapy.
Project FrontRunner:
Focuses on developing a framework for identifying drugs suitable for early metastatic disease treatment, with the goal of facilitating earlier approvals in the first- or second-line setting.
Real-Time Oncology Review (RTOR):
Streamlines the review process for oncology products, enabling faster access to safe and effective treatments.
___
Cytodyn & Leronlimab qualify @ all thee above...
Add the very most recent FDA changes & regulatory should be all asked for -- judged on only Leronlimab
Project Optimus:
Aims to reform the dose optimization and dose selection paradigm in oncology drug development, moving away from the current model based on cytotoxic chemotherapy.
Project FrontRunner:
Focuses on developing a framework for identifying drugs suitable for early metastatic disease treatment, with the goal of facilitating earlier approvals in the first- or second-line setting.
Real-Time Oncology Review (RTOR):
Streamlines the review process for oncology products, enabling faster access to safe and effective treatments.
___
Cytodyn & Leronlimab qualify @ all thee above...
Add the very most recent FDA changes & regulatory should be all asked for -- judged on only Leronlimab
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