To me solithromycin is a direct analog of tolithromycin (Ketek), which got pulled from the market due to Liver toxicity, I'm just having a hard time envisioning how by putting an aniline ring in the drug will fix the problem.
there is a reason Aniline moieties are not found in drugs...look for yourself.
Anyway, I'm not saying that this won't be a great pdufa play, it probably will be, I don't see any problems with phase 3 safety as even tolithromycin had a relatively clean clinical development profile. It was not until Tolith. was giving to the general public that it reared it ugly head.
one poster posted QUOTE this drug has a big old nasty aniline moiety on it...does anyone have any convincing data that this drug doesn't destroy the liver...heck put an aniline on a drug and you might as well throw a hand grenade in your liver. QUOTE