• Wafermine® reaches the final regulatory step. With four milestones completed, only FDA grant of EUA remains pending.

The Declaration confirms that circumstances exist for the FDA to consider Wafermine® for EUA. Before the Declaration, supply of Wafermine® to US military personnel would have required full FDA approval. With the statutory precondition under section 564 now satisfied, a regulatory route exists, subject to the FDA granting an EUA. Together, the DOW Award and the Declaration bring the funding, development programme and regulatory pathway into alignment, materially advancing and de-risking Wafermine®.

Mr Eddy Lee, Chairman and CEO of iX Biopharma, said,

“No company can bring about a declaration of this kind; it requires the US Government to act, and declarations under this pathway are extremely rare. That the US Government has taken this step validates what we have said about this programme throughout – Wafermine is being developed within a US government-supported programme addressing a critical unmet medical need. Our focus now is completing the EUA submission and getting Wafermine to US military personnel urgently.”

See link for full media release: https://www.ixbiopharma.com/newsroom/