Thinly traded micro cap Recro Pharma (NASDAQ:REPH) is up 14% premarket on average volume in response to its announcement that, based on its meeting with the FDA, it will refile its marketing application for IV meloxicam by the end of the month. The revised NDA will incorporate revised language related to labeling and additional information on extractable and leachable items.
The company received a CRL in May citing data from ad hoc analyses and selected secondary endpoints that undermined its claimed efficacy.
Previously: FDA rejects Recro Pharma’s marketing application for IV meloxicam (May 24)
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