ImmunityBio Requests An Urgent Meeting With FDA To Address The Change In The Agency’S Unambiguous Guidance On Jan 2025 To Submit A SBLA For NMIBC BCG Unresponsive Papillary Disease, Following An Inconsistent Refusal To File Letter On May 2, 2025
ReutersMay 5, 2025 10:35 AM
May 5 (Reuters) - Immunitybio Inc IBRX.O:
IMMUNITYBIO REQUESTS AN URGENT MEETING WITH FDA TO ADDRESS THE CHANGE IN THE AGENCY’S UNAMBIGUOUS GUIDANCE ON JAN 2025 TO SUBMIT A SBLA FOR NMIBC BCG UNRESPONSIVE PAPILLARY DISEASE, FOLLOWING AN INCONSISTENT REFUSAL TO FILE LETTER ON MAY 2, 2025
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