Your Daily Scoop: Recro Proceeds, MannKind Zooms, Aduro's Publication [Seeking Alpha]
Recro Pharma, Inc. (REPH)
Last recro pharma, inc. earnings: 11/8 07:00 am
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US:NASDAQ Investor Relations:
ir.recropharma.com
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Source: Seeking Alpha
Summary News in focus: REPH, MNKD Recro Pharma plans to resubmit NDA Discussion : On September 4, Recro Pharma ( REPH ) reported positive outcome of its meeting with the FDA regarding its NDA for IV meloxicam that was rejected in last May. Based on the discussion with the FDA, the company now plans to submit a revised NDA by the end of this month. Suggestions offered by the FDA now guides the company to include revised labelling language and further information on extractable and leachable items. The May CRL included ad hoc analysis of the trial and reports on secondary endpoints that undermined the candidate’s efficacy claims. Meloxicam is a sustained cyclooxygenase (COX-2) inhibitor that leads to subsequent reduction in prostaglandin biosynthesis. This chemical property endows the drug with analgesic, anti-inflammatory and antipyretic activities. However, before becoming REPH’s lead candidate meloxicam has an established clinical history. Since 1990s, Boeh
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