FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases
https://www.fda.gov/news-events/press-announc...e-diseases
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100% relates to Mr. Hoffman said Cytodyn will be filing a BTD. Approved, & that unlocks Rare Disease status for poyentially 100's of RD's for LL.
Keep in mind, the FDA also recently allows all data from your various trials, including eIND, Right to Try, etc., for receiving Platform Status
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