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May 28, 2014
08:05 EDTRMTIRockwell Medical announces FDA acceptance for filing of Triferic NDA
Rockwell Medical announced that its New Drug Application, or NDA, for Triferic has been accepted for filing by the FDA. Triferic is the company's iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. The acceptance of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act action date of January 24, 2015. The PDUFA action date is the goal date for the FDA to complete its review of the NDA.
News For RMTI From The Last 14 Days
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October 17, 2014
15:15 EDTRMTIRockwell Medical volatility elevated
Rockwell Medical November call option implied volatility is at 164, January is at 121, February is at 122; compared to its 26-week average of 76 according to Track Data, suggesting large price movement into a PDUFA Date for Triferic on January 24, 2015.
October 9, 2014
07:33 EDTRMTIRockwell Medical announces FDA advisory committee review of Triferic
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