Imaging Biometrics, a wholly owned subsidiary of IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF), intends to modify and resubmit its application for Paediatric Rare Disease (PRD) Designation, in response to a letter from the US Food and Drug Administration (FDA) encouraging a resubmission for a narrower target population.
Imaging Biometric said it is actively working on the request with plans to resubmit by the end of next week.
Per the FDA's response, "paediatric brain tumours" is too broad of a term and, with recent nomenclature changes made by the World Health Organization (WHO), now includes many distinct brain tumour types and subtypes; all of which vary in severity.
Since low-grade tumours are not necessarily terminal, they should not be included in the request, said the FDA.
The detailed guidance provided by the FDA identified the exact subtypes to include in the resubmission.