Is there a reason that an ex-US trial has to be poorly run?
No, but there is an increased risk and I don't understand the justification for it.
Handicap the success of what? Anemia, Proellex, Repros? I can pull numbers out of my butt for any one of those, but if you are looking for an exact quantification of the risk, I'm not the guy to give it to you. I like the company, I like the drug, I'm invested but I'm not thrilled with this trial.
I would have been happier with larger trials and with no x-US. If that's carping, I guess I will live with it.
How many drop-outs or improperly enrolled patients will it take to screw the numbers with such small trials? What are the odds that a patient will decide against surgery after treatment, and how will this be treated in the trial? There are questions here without even touching on the multiple doses.
I find it healthier for my wallet to be paranoid about this stuff.
Bob