Biotech Values

[dewophile]

FGEN/AKBA

I agree w you that it does seem patients tachypylax w daily doses. AKBA is also acutely aware of the FGEN data (how can they not be). So i am not quite sure their rationale for moving forward w daily dosing and TIW. Perhaps regulatory agencies required more data on TIW in the NDD population (where only QD is being studies in phase 3) and they didn't want that to hold up the trial. That doesn't seem wise given the costs of these trials and theoretical risk of narrowing the therapeutic window. You are always better off doing more dosing studies to get it right before a huge endeavor like these trials require if you ask me, even if it means a significant delay, but obviously AKBA doesn't seem to share these concerns (and perhaps this is justifiable they obviously are privy to more data than is available publicly). That said, to be testing 2 different dosing regimens in phase 3 is odd and potentially problematic - e.g. how can you aggregate safety data across trials that way? I don't own AKBA but I sure as heck would want to know management's rationale re dosing vs FGEN before investing