CatalystWireBeta

Application for Pediatric Rare Disease Designation

In brief · summary, not quotable

No summary for this filing – the full text is below.

Full announcement

Select text to share a quote on X · sign in to keep highlights & notes in your IBAI notes

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.

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

Cleaned text: letterheads, contacts and legal notices removed. View the original announcement ↗ · Company filings. Not investment advice.

Share this quote

Quote card
Post on X WhatsApp Download image

The link opens this announcement with the quote highlighted. Quotes are checked against the original text.

Add a note