9th Feb 2024 13:38
(Alliance News) - IQ-AI Ltd on Friday said its subsidiary Imaging Biometric LLC will modify and resubmit its application to the US Food & Drug Administration.
The St Helier, Jersey-based medical services firm said Imaging Biometrics' application for paediatric rare disease designation will be altered after the FDA encouraged a resubmission for a narrower target population.
Imaging Biometrics is working on the request and plans to resubmit by the end of next week.
"Per the FDA's response, 'pediatric brain tumour'" is too broad of a term and, with recent nomenclature changes made by the World Health Organization, now includes many distinct brain tumour types and subtypes; all of which vary in severity," IQ-AI said.
"Essentially, since low grade tumours 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," it added.
Shares in IQ-AI fell 0.4% to 2.55 pence each in London on Friday afternoon.
By Sabrina Penty, Alliance News reporter
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