News Focus
News Focus
Followers 12
Posts 261
Boards Moderated 0
Alias Born 08/27/2013

Re: biodoc post# 75410

Sunday, 10/26/2014 1:48:59 PM

Sunday, October 26, 2014 1:48:59 PM

Post# of 405218
Either you answered incorrectly or misinterpreted NR's question.

No, it is absolutely not the case that every lesion must show >=20% reduction for the trial to be considered a success.

That criteria applies to each indivdual patient in the itt population to rate each as a clinical success or not. A statistcal comparison is then made between the percentage of patients rated as clinical success within each treatment arm.

The positive top line data announced by Cellceutix means that these percentages for the B arms were all within the statistcal uncertainty for the D arm, or something like that. They were "comparable". I don't know if this was an equivalence or non-inferiority trial.

So there are numbers we don't have here yet. Say D had a clincal success rate of 90% at 48 to 72 hours, if the B arms were all at 85% they'd probably still be within statistcal uncertainty and make the trial a success.

The numbers are important for projecting the chances of success in the phase 3. I believe it has to be a non-inferiority trial and some margin must be agreed on with the fda that we must reach.

Edit: It sounds like it's a non-inferiority trial with a margin of 10%, so if D was say 90% B would need to be at least 81%
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y