Clearly the FDA is involved with the interim results. As pointed out by Bill on yahoo msg board, NP had earlier said that as part of the FDA’s overall analysis of LL in the mm trials that they also wanted to see the sc interim results.
“In the FOX video (post CD-10 results discussions) Nader said the U.K. and FDA has asked for our interim analysis of our critical to severe trials!
Nader said this around 1 minute into the interview with the Fox News host (see link below)!”
Wouldn’t this imply, that the sc interim test results would have to be unblinded w/o any penalties!???