Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-498

So far, the handling of results shows management is playing catchup with the science.
I would like to know if all study sites were working from exact same protocols, it may seem obvious, but you never know.
With such a pivotal study, you must question the experience of the team members at each site.In the US, was there a bunch of uni kids getting hands on experience during summer vacation? Or even research masters students?

I know when I did my first summer cadetship, it was after second year uni, was given quite an important project and screwed up plenty of times, though I followed protocol and was even given the responsibility to write a new one! Plus, the post grads were even worse than me, some didn't follow protocol, which is the most elementary and crucial input in a study.
So all I am saying is, study teams can easily make mistakes (through own doing or from extrinisic factors of which they aren't aware) that can end up being monumental and they are all different in how they run and delegate during investigations.
In this study, timeframe is the guiding factor, so once it's well in progress, the horse has bolted. If they found out sometime during the US studies that there was a mixup, could they pull the pin? Or could they remove those patients affected by the mixup? Well that would mean ceasing the whole operation. Would the scientists want to tell their sponsor mid-study that there was a huge screwup, or something looked very wrong? I surely cant answer that, but I would imagine they would continue as they are already committed to completion.

BOT could not have been micromanaging any of the science teams, so now they need to completely investigate before making a true and reasonable statement as to why the results don't add up. I don't think that alluding to manufacturers that they don't use anymore as "potentially" being the problem is helping and certainly not impressing shareholders at the moment.