REG - IQ-AI Limited - Application for Pediatric Rare Disease Designation

IQ-AIAnnouncement

08/11/2023 11:00

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RNS Number : 8043S  IQ-AI Limited  08 November 2023

IQ-AI Ltd

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

IQ-AI Applies for FDA Pediatric Rare Disease Designation

November 8, 2023, Imaging Biometrics, LLC (IB), a wholly owned subsidiary of
IQ-AI Ltd (LSE: IQAI, OTCBB: IQAIF), is pleased to announce it has submitted a
Pediatric Rare Disease ("PRD") request to the US Food and Drug Administration
("FDA") for oral gallium maltolate ("GaM") for the treatment of pediatric
brain tumors.

The RPD program is intended to encourage the development of new drugs for the
treatment of rare pediatric diseases and is granted by the FDA for serious or
life-threatening diseases which affect fewer than 200,000 people under the age
of 18 years in the U.S.

If IB's application is successful, the PRD designation provides incentives
including eligibility for a priority review voucher that can be redeemed for a
subsequent marketing application. This voucher can be used to reduce the time
of an FDA new drug approval review or could be transferred (sold) to another
company.

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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: 020 7469 0930
 Peterhouse Capital Limited (Financial Adviser and Broker)

 Lucy Williams/Heena Karani

 Tel: 020 7220 9797

 

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 at www.imagingbiometrics.com
(http://www.imagingbiometrics.com/) . Follow IB on Twitter, @IQAI_IB.

 

 

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