Modalis Therapeutics Corporation announced that on June 23, 2023 (U.S. time), received Pre-IND (Type B) response from the U.S. regulatory agency, the FDA for MDL-101 program. After positive animal proof-of-concept results in rodent and target engagement in non-human primate studies and pilot manufacturing, Modalis submitted a Pre-IND meeting request and briefing package with the FDA's Center for Biologics Evaluation and Research (CBER) earlier this year to further advance development toward clinical trials. The Pre-IND review request is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on preclinical and clinical trial design, clinical materials manufacturing, quality controls, etc.
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Apr. 15 | Modalis Therapeutics to See Reduced Expenses of 250 to 350 Million After Cutting Jobs | MT |
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