Re: Resverlogix Reaches Agreement With FDA for Key Aspects of Apabetalone Registration Enabling Study
posted on
Jun 22, 2020 09:00PM
Toinv you are not off track. I believe that if CHF had replaced stroke, BETonMACE would have been an overwhelming success with the powering that was used. I had heard that those discussions had taken place with the FDA prior to the start of BoM however it was determined that stroke had to be used. The biggest single factor in not achieving the expected numbers seemed to be the inclussion of SGLT2's and DPP4's as SOC drugs. We can only hope that the designers of BoM2 take not only these drug reactions into effect in their design but also any drugs that have become SOC in the last 5 years.
tada