FDA Application Update

Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI Ltd (LSE: IQAI), reports that it will modify and resubmit its application for Pediatric Rare Disease (PRD) Designation, in response to a letter from the FDA encouraging a resubmission for a narrower target population.

IB is actively working on the request with plans to resubmit by the end of next week.

Per the FDA's response, "pediatric brain tumors" is too broad of a term and, with recent nomenclature changes made by the World Health Organization (WHO), now includes many distinct brain tumor types and subtypes; all of which vary in severity. Essentially, since low grade tumors are not necessarily terminal, they should not be included in the request. The detailed guidance provided by the FDA identified the exact subtypes to include in the resubmission.

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