exwannabe,
I agree that this SGEN top line announcement is fairly typical. If there is clear distinction from the analysis with regard to P values and confidence intervals I believe this is how top line will be announced for L. On the other hand, if the comparison becomes more complex due to crossover and later enrolled patients receiving extra benefit from some source like the use of 5-ALA or other, like "optimization", then there may be a more complex explanation or more probably a simpler one given for top line that gets explained at a later date unless the SAP is truly bought into by all parties. A normal SAP is no problem for companies. For this trial every concern by regulators must be addressed to the very best of NWBO's ability because as you said, regulators are not "approving" the SAP before their decision to approve the treatment even if they are commenting on it. As you said before, there is nothing normal about this trial.
Fraunhofer made a comment that everyone needs to take into greater consideration. They said they only enrolled to the point of statistical necessity which means someone had to have had a look at blinded data, made a call and passed that call on to Fraunhofer. After that call only treatment patients were given access to this trial and Fraunhofer had to have enrolled all treatment arm patients they had planned to enroll as all planned for treatment arm patients were enrolled which suggests strongly that they did not enroll their complete quota of SOC patients since they only enrolled the number statistically necessary instead of reporting that they had enrolled their entire planned for cohort. Notice that Fraunhofer made this statement public only after primary and secondary completion data had been secured which is a critical point to consider with regard to trial integrity. I believe that NWBO and regulators wanted to wait for separation between those whose resection techniques were different and or those that received a Fraunhofer "optimized" version. The ultimate decision to explain or unblind of course depends on NWBO but that decision most assuredly was influenced by blinded data and late separation being noted in that blinded data between groups of patients treated before Europe, or Germany alone, and those that enrolled afterwards. If the influence was believed to have been more 5-ALA related synergy by those reviewing blinded data then maybe that group has been separated out for distinct analysis. What is certain is what you said before about nothing being "normal" about this trial. Best wishes.
