FDA Orphan Drug Designation and completion of FDA INTERACT meeting for BVX001 in the treatment of AML announced
Tiffany Thorn, BiVictriX’s Founder and CEO commented: “The ODD grant for our lead asset BVX001 represents important US regulatory progress for BiVictriX, highlighting the significant unmet need for novel therapies targeting AML and providing us with greater market exclusivity potential. The INTERACT forum gave us clear and timely guidance from the FDA on BVX001, and we consider the feedback to be very positive. With strong alignment between our future development plans and the comments from the FDA reviewers, it is an exciting time for the Company. We continue to advance our preclinical data package for BVX001, with plans to submit a pre-IND application, and to present further efficacy and safety data at a key Haematology Conference in the second half of 2024.”
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