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Re: None

Wednesday, 03/06/2019 9:16:35 AM

Wednesday, March 06, 2019 9:16:35 AM

Post# of 43847
55% or 63% SOC

The 55% SOC survival rate at 36 months includes stage 3 and stage 4 patients.

The 63% SOC survival rate at 36 months only includes stage 3 patients.

The FDA and CVM agreed at the start of the trial that the Phase 3 patient characteristics including age, gender, geography, stage of cancer, etc would show "about 55%" SOC survival based on data from 10's of thousands patients from various age groups, gender, geography, and stage of cancer (very reliable data).

I can see where the SOC may have moved up slightly over the last 8 years, however, not THAT much, especially since no new drugs have improved the SOC in the last 8 years. A new drug could improve the SOC survival rate a large distance from 55% to 63%, but no drug has been approved to help SOC.

Questions:

1. If the Phase 3 is using a mix of stage 3 and stage 4 patients, then how come the spreadsheets want to keep using 63% for SOC arm?

2. The U.K. study showed stage 3 patient survival rates of 63%....so why would spreadsheets guessing on the 298 use only stage 3 patients data instead of a mix of stage 3 and stage 4 patients in the Phase 3? (
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