Questions
1. Why was phase 2 calculated as "improvement over standard of care" using the percentage difference, divided into the bottom number (SOC), whereas the recent P3 results are called "survival advantage" and simply substracts the percent points of one treatment with MK over the non-MK treatment? This is like saying that 20% is 100% improvement over 10% in P2, but in P3 saying it's only 10% points higher. Isn't it the legal submission standard to do the former? Until Monday we all used the ISO improved survival term as the main purpose of the study, now all of a sudden we use “how many points above” soc do we have as an “advantage.” It’s as if every spreadsheet and P2 reference was talking about a different study
2. Why is SEER not used for overall benefit since it's being submitted as a HNC drug, and not just a drug that performed with this SOC 298 population? There are decades of data going into SEER and the results of our P3 is a lot better than those averages.
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