The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the second RTF letter issued by the FDA this week, the first to Acorda Therapeutics on Tuesday.
SteadyMed 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.
The company said it plans to request a meeting with the FDA to better understand what it needs to resubmit its application.
“We believe that the issues raised in the letter from FDA can be sufficiently addressed. Our next step is to work with the FDA to address the open issues and identify a path to a successful resubmission and acceptance of our application,” president & CEO Jonathan Rigby said in prepared remarks. “We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and remain committed to bringing the product to patients in need.”
The company’s product combines United Therapeutics‘ (NSDQ:UTHR) drug, Remodulin, with SteadyMed’s PatchPump infusion system for patients with pulmonary arterial hypertension.
See the best minds in medtech live at DeviceTalks Boston on Oct. 2.
The post SteadyMed shares tumble after FDA refuses to review Trevyent NDA appeared first on MassDevice.
from MassDevice http://ift.tt/2eHUbW0
Cap comentari:
Publica un comentari a l'entrada