Paladin’s Impavido Poised For Smooth Advisory Committee
This article was originally published in The Pink Sheet Daily
FDA reviewers did not identify any major problems with the application for treatment of three types of leishmaniasis, but did say the product may face resistance problems as use expands.
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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.