Polyrizon Ltd. announced today the submission of its full pre-submission (Pre-Sub) package to the U.S. Food and Drug Administration (FDA) for its PL-14 product. PL-14 is designed to help individuals suffering from nasal allergies.
The comprehensive submission includes detailed documentation covering manufacturing plans, clinical development strategies, and regulatory pathways. This represents significant progress in Polyrizon’s regulatory strategy, paving the way for potential marketing clearance.
Tomer Izraeli, CEO of Polyrizon, stated that this is a crucial step in the journey to bring PL-14 Allergy Blocker to market. Allergic rhinitis affects hundreds of millions globally, and this submission positions Polyrizon for accelerated development in this high-demand therapeutic area.
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