Incorrect design trialMore I think about this call, more I think they incorrectly design the trial and won't ever admit, Jan need to be replaced.
Its impossible that they can't control a placebo arm. If its the case, other trials would have fail and no investor would invest in a R&D if they can't control the placebo arm.
Basically, the trial was incorrectly design, patients should not have been put on a severe diet during randomization, because it reduce significantly the TG, this is not rocket science.
Also, how could patients would be >500 mg/dl between randomization and under <500 mg/dl at week 0 and still be accepted as part of the research, it was designed for a fail.
Are only hope is that T2 has not the same effect.
Management should leave.
The conclusion, is that drug work, but trial incorrectly managed by incompetents