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APL-130277APL-130277 is a reformulation of an approved Parkinson’s drug. APL-130277 is a novel oral formulation of an approved drug for Parkinson‘s patients designed to deliver significant clinical benefits over the current marketed treatment. The drug will treat patients with moderate to severe PD and address a significant unmet clinical need as expressed by clinicians and patients. The drug is expected to undergo accelerated approval through 505(b)(2) FDA regulatory pathway with the US FDA and a similar pathway with other international regulatory agencies. This well developed regulatory path could result in a New Drug Approval application being submitted in late 2014 or early 2015. APL-130277 has the potential to address a significant underserved portion of $3.5 BillionParkinson’s Disease market.
Download Recent Parkinson's Disease Survey Results here.
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