IQ-AI Limited FDA Application Update
09 February 2024 - 11:49PM
RNS Regulatory News
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: 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
atwww.imagingbiometrics.com. Follow
IB on Twitter, @IQAI_IB.
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END
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