Biotech Values

[DewDiligence]

MDGL did not adhere to the published endpoints—that's what the controversy is about. The discrepancy has to do with changing "no worsening of NASH" to "no worsening of NAS." This may sound like a small change, but it isn't.

"No worsening for NAS" allows the three components of NAS (steatosis, ballooning, inflammation) to be numerically added so that a worsening of one component may be offset by an improvement in another component. OTOH, "no worsening of NASH" requires that the ballooning and inflammation components of NAS not get worse, regardless of any improvement that may have occurred in the steatosis component.

I initially had a hard time believing that MDGL was playing this kind of trick on investors, but that is what they did.