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Pre-NDA Discussion with FDA for MP-376 in Cystic Fibrosis Scheduled for 2Q 2016

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Additional Information

Additional Relevant Details Raptor Pharmaceuticals plans to meet with the FDA in a pre-NDA meeting in the second quarter of 2016 to discuss its lead development drug MP-376 for the treatment of cystic fibrosis.  A pre-NDA meeting usually occurs towards the end of clinical development.  
http://ir.raptorphar...
Additional Relevant Details MP-376 (Investigational Form of QUINSAIR)
  • Raptor had a meeting with the FDA in the second quarter concerning MP-376 for the management of chronic pulmonary infections due toPseudomonas aeruginosa in adult patients with cystic fibrosis in the U.S. The FDA requested additional information pertinent to Raptor's existing trials prior to the company's potential submission of an NDA. Raptor submitted a response to the FDA's request and expects to have additional discussions with the FDA.
http://ir.raptorphar...
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Catalyst Date
Occurred on:
May 19, 2016
Occurred Source:
Related Keywords Pre-nda Discussion, Fda, Cystic Fibrosis, Mp-376