I didn't read all of that from the S-3, just the continue, and the timing. My guess from day 1 has been that the hold was for an efficacy look to serve 2 purposes.
1) German Reimbursement amount... if any.
2) Continue, Terminate, or Early Approval (whatever the correct term is).
They stopped when they had 300 enrolled / randomized, right? That was the original full enrollment plan. Ie, that was the required enrollment to reach statistical significance if the efficacy was what they had originally targeted / hoped for. They wanted to take a look there for possible early (original plan on-time) termination, and that allowed the German reimursement look at the same time without whatever that additional statistical bias expense is for the trial. Really the same look. Probably planned long ago.
If it was early termination with a confirmatory, I don't think they would have worded their reasons for continued site expansion the way that they did.
Or... not.
News 
Market Data 
Discover 
AI
