"Further, given where we are now in this trial, we also need to consider the almost total absence of any safety issues, which is remarkable as this arguably is often a game-changer for many drugs under development (I’m guessing…?).  To wit, consider how many drug ads you see on TV that often equates taking those drugs to the potential risk of having a near death experience!  Apabetalone may have almost none of that."

Paladin, great post. However, you are reading too much into the fact that the nine DSMB reports have had no safety issues. The lack of DSMB safety comment likely means that there's nothing warranting trial halt that is serious enough, consistent enough or interpreted by clinical investigators to be drug related. Only once the full data is presented and/or published at/in a major scientific meeting/journal will the complete list of adverse events be available for scrutinizing.

There are always adverse events. Every drug has them. They don't have to occur in all patients to be found to be statistically associated with drug exposure. We already know that apabetalone will have higher incidence of liver transaminase elevation in some patients. There will likely be more adverse event associations with apabetalone beyond liver transaminases. Importantly, this is completely normal with drug development and does not necessarily affect the probability of FDA/EMA approval.

The FDA/EMA regulatory agencies will be the ones to interpret and conclude whether the adverse event profile is acceptable for approval. But long before that point the full data with comprehensive adverse event and safety data will be presented or published. How will investors, analysts, doctors, etc interpret this safety data? How will the share price be affected in the immediate short-term after full safety data release? Will it be a fair reaction or an over-reaction? Will the magnitude of the MACE, renal function and cognition benefits allow for the safety data to be more palatable?

BearDownAZ