Re: Breakthrough Designation
in response to
by
posted on
May 28, 2020 01:38PM
good point..
and from press release...RVX "entails working closely with the FDA to facilitate a...development program including planned clinical trials and plans for expediting the manufacturing development strategy for apabetalone."
If one considers how overwhelmed FDA must be on the COVID front, it's not surprising this is taking so long.
---------------------
"This extremely exciting development significantly supports our commercialization plans for apabetalone,” said Donald McCaffrey, President and CEO. “The FDA recognizes that apabetalone, in combination with top standard of care therapies, is a novel way to address a major unmet need. This important designation – the first for a major cardiovascular indication – entails working closely with the FDA to facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy for apabetalone. We look forward to working with the FDA on next steps and updating our stakeholders on future material developments.”