Cel Sci Corporation (CVM)

[Biobonic]

There is one data point that is certain

There have been 298 events.

Other data points can be assessed as being within a range.

Dropouts: The study was originally designed to assess the trial endpoints with a minimum of 784 patients (2016 Annual) The two comparative arms contain 6/7 of the total patients or 398 each arm (796 total). The minimum patient population in those two arms would need to be 6/7 of 784 or 672.
796 total enrolled and minimum needed is 672. 124 can drop out or 15.5% and still meet the trials original design for statistical power.

SOC (Standard of Care) OS (Overall Survival) There is a range for that.
Range of OS for the SOC group chosen for this exercise was from 42%-56%

Using those two ranges and the certain event total of 298

Below is calculations of Multikine increased Overall Survival %

-----------------------Dropout Rate as a %------------------
--------------------------4------6------8------10------12------14---

SOC OS--42%----.90----.86----.82-----.78----.73----.69---

SOC OS--44%----.77----.74-----.70----.65----.61----.57---

SOC OS--46%----.65----.61-----.58----.54----.50----.46---

SOC OS--48%----.54----.51-----.47----.43----.39----.35---

SOC OS--50%----.44----.41-----.37----.33----.30----.26---

SOC OS--52%----.35----.31-----.28----.24----.21----.17---

SOC OS--54%----.26----.23-----.20----.16----.13----.09---

SOC OS--56%----.18----.15-----.12----.08----.05----.02---


IDMC appears to have noted the dropout rate in it's correspondence to CVM (Letter to Shareholders Feb 2020)

In reviewing the conditional power and sample size the IDMC would be considering the dropout rate. If there was a problem with the dropout rate, then per the Charter the IDMC is required to tell us to enroll more patients. They have not done so.

Based on the above, chose not to go above the dropout rate of 14%.

For entertainment purposes only...

I see the sweet spot between 48%-52% SOC OS and Dropouts 8%-12%
But then again, this is just an educated guess.

I wish to thank Excel for their behind the scene's work