When NP answered my question about sufficient data

When NP answered my question about sufficient data going to Cytodyn it was unclear what NP was referring to about one person at Amarex. From FDA guidelines using a statistician from the CRO could be considered a compromise of the data and we get a penalty anyway. I've also seen some misunderstanding of what the penalty entails. There would be no penalty on the data if a submission was made to the FDA on the interim results. There would only be a penalty if the data was unblinded at interim and either the FDA or Cytodyn decided the trial needed to be completed. The penalty would be on complete trial results due to compromised data.