Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent.
SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the FDA in June, but the federal watchdog has requested more information on certain device specifications and performance testing, as well as additional design verification and validation testing.
Now, SteadyMed is looking to meet with the FDA to discuss its RTF letter and a path to resubmission.
The company said today that it submitted a Type A meeting request and briefing document to the FDA, which it expects to hear back about within 30 days.
““We believe that we have provided a briefing document that will allow us to work collaboratively with FDA to agree on a pathway to resubmission of our NDA for Trevyent,” president & CEO Jonathan Rigby said in prepared remarks.
“We look forward to meeting with FDA in the near future.”
The company’s product combines United Therapeutics‘ (NSDQ:UTHR) drug, Remodulin, with SteadyMed’s PatchPump infusion system for patients with pulmonary arterial hypertension.
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