Re: Breakthrough Designation
in response to
by
posted on
May 28, 2020 07:36AM
...so it appears that this topic was bounced around on Stockhouse 2 weeks ago
All I can say...look at the March 30th news release
https://www.resverlogix.com/investors/news?article=663
it states multiple times that we have it
“We are very encouraged by the results presented in JAMA and the accompanying editorial – which is based on the large Phase 3 trial, BETonMACE – the first ever testing a BET inhibitor for a cardiovascular disease indication,” said Dr. Michael Sweeney, Senior Vice President, Clinical Development of Resverlogix. “The addition of apabetalone to standard of care therapy in the trial’s high-risk patient population showed a strong trend towards a reduction in major adverse cardiac events (MACE) and hospitalization for heart failure. Apabetalone’s strong safety profile, along with the latest published results, allows us to move this novel therapy into a subsequent study under US FDA granted Breakthrough Therapy Designation to enable a New Drug Application filing.”
and again from the same release:
Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.
...also included in March marketing materials (fact sheet)