looks good here
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Sarepta’s eteplirsen has a target PDUFA date set for February 26.
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Dave Lee North America technology reporter
25 January 2016
Capital Market Laboratories
WHAT JUST HAPPENED
We thought Relypsa would released data that could limit the blackbox label to three hours rather than six. We just found out the entire blackbox could go away.
Relypsa Announces Results From Veltassa Drug-Drug Interaction Studies in Healthy Volunteers. Here are the details.
Relypsa reports results from Phase 1 in vivo studies in healthy volunteers evaluating potential drug-drug interactions between Veltassa and 12 drugs administered either at the same time or three hours apart
1. Results of the Phase 1 studies showed nine of the 12 drugs tested showed no clinically meaningful reduction in absorption when administered at the same time as Veltassa
2. No reduction in absorption was observed for any of the 12 drugs tested with a three-hour dosing separation from Veltassa
Funds Sellinf Sarepta Before Adcom
read the FDA document