Replies to post #17766 on Cel Sci Corporation (CVM)

[lightrock]

Response Rate

If I blow pollen in your face and you sneeze, then you have a response to pollen. You might have allergies.

If Inject you with something, and you have a reaction of any kind, you have responded to the injection.

In the Phase II Trial, there is a number, "Of all the people injected, how many showed some sign that there is a response to the injection".

We know that this number is not 100% in the PII study.

The bullets that we shoot, bounce off of approximately 50% of the people we shoot. So, we only stand a chance of causing a change to about 50%.
( From the phase II study, "response rate". It was a small study. )

"Response Rate" applies to the "Test" group that are properly given MK.
i.e., "It has no effect on half the people you gave it to"

Before anyone runs around with their hair on fire, you can say the same thing for the already approved drugs like ipilimumab and nivolumab.

Being able to scientifically demonstrate that your drug does work ( at least sometimes for some people ) - which is about what all other successful drugs in this space do - is what this is all about.

The phase II study appears to suggest that "Wow, IF you have a response to MK, then it is dramatic".

The fact that there is a response rate, affects how you should look at your statistical efforts (before during after) not just as a scientist but anyone trying to make a statistical model to rustle up an idea of when this study might conclude.

If the Phase III study follows the response rate that occurred in the Phase II study, then about 50% of those injected with MK will not show any effect and they will equal the Standard of Care statistics and not show a 10% better (or worse). Those that do show a response, hopefully do live longer.

Start with people in two groups. 50% test, 50% control.

You know that 50% of the test group will have no response. ( as per the information available about response rate.

75% of ALL will show the same statistics, as if 75% are in the control group.

The burden is on 25% of the total (100% of test+control) to demonstrate effectiveness.

If 100% of the Test Group has a Response, then the study will take longer as 50% of the total (presumably will be living longer). With a 50% response rate, only 50% of the test group (25% of the total) will show a response and the total rate of events will be higher ( shorter calendar time )