Re: Can we infer perhaps that BETonMACE is properly powered from the FDA news?
posted on
Jun 17, 2018 09:52PM
I don’t think you can infer that the trial is properly powered from the NR as 1) the FDA has not been privy to unblinded info and 2) the NR basically says the FDA believes the trial will put Apabetalone on the path to registration if the trial is successful as designed. Key word “if”. Success could still mean that, according to the plan, the trial may need be altered for statistical purposes.
For me, I will not assume the trial is going to proceed unaltered to completion until the company unequivocally states such.