Paladin’s Impavido Could Set A Price Tag For Priority Review Vouchers
This article was originally published in The Pink Sheet Daily
Approval of the leishmaniasis treatment by its December user fee date would give the Canadian sponsor a voucher for a priority review, which it is likely to sell to another company.
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But the small Canadian specialty company says it will be patient in finding the maximum value for the asset, awarded in connection with FDA approval of its leishmaniasis treatment.
FDA clearance of the Morquio A syndrome treatment provides some insight into how the agency is implementing the 2012 priority review voucher program aimed at incentivizing development of treatments for rare pediatric diseases.
Anti-Infective Drugs Advisory Committee votes to recommend approval of leishmaniasis treatment, but questions about a post-marketing study on dosing in heavier patients linger.