IQ-AI Limited FDA Application Update

RNS Number : 6911C

IQ-AI Limited

09 February 2024

 

IQ-AI Ltd

("IQ-AI" or the "Company")

 

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.

 

--ENDS-

The Directors of the Company accept responsibility for the contents of this announcement.

 

For further information, please contact:

 

IQ-AI Ltd Trevor Brown/Vinod Kaushal/Brett Skelly/Michael Schmainda Tel: [phone]

Peterhouse Capital Limited (Financial Adviser and Broker) Lucy Williams/Heena Karani Tel: [phone]

 

 

 About Imaging Biometrics® LLC:  IB is a wholly owned subsidiary of IQ-AI Limited, (LON: IQAI), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company's website atwww.imagingbiometrics.com. Follow IB on Twitter, @IQAI_IB.

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END

 

 

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