Wow, Ex thinks he is smarter than the 73 coauthors who indicated Stat Sig. Ex, what are your credentials to make such a statement? I doubt you even have a Liberal Arts and Science Degree. The Professionals who coauthored also actually provided their name, you can pull up the list. Do you have more credentials than any of them? Of course you don’t or you would have a real job.
The key rule is that the change cannot be based on information from the trial.
wrong. The key rule is that the amendment of endpoints, should not be made by someone with trial bias such as Dr Bosch or Dr Liau. Therefore Duffy was brought in without previous SAP/SPA/IA knowledge to lead the endpoint amendments.
But then again your knowledge of FDA regulations has always been iffy
You're right. They knew most patients, even those on placebo who crossed over were living too long. Therefore they knew that dcvax was working. And they proved that it works as published in jama. The mhra will agree with them in short order. The rest (including you) will soon be history.
See the following figure? The figure clearly shows that there must be massive t-cell infiltration into tumor site. T-cells have to show up at tumor site first and then keytruda can unmask t-cells and let them recognize tumor cells and then eliminate them. It is simple and beautiful truth. Why do you keep ignoring it?