Cel Sci Corporation (CVM)

[Biobonic]

Thanks Fosco,

In presentations I hear Geert mention that he is blinded, and that he does not recommend that for a small biotech for nine years. In reviewing designs of clinical trials I find a number that have periodic data reviews built in.

As to the point of what is the IDMC reviewing, I do find these statements from the Feb 2020 Letter to Shareholders to be informative:

In addition, the actions by the Independent Data Monitoring
Committee (IDMC) speak against that as well. The IDMC, which meets
periodically to review the study and data in an unblinded manner (i.e., they see everything) is tasked with focusing on the following areas:

* Efficacy: to assess the primary efficacy measure as well as the
conditional power and sample size

* Safety: to assess the magnitude of adverse events and monitor for
safety concerns

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. As recently as October 2019, the IDMC recommended “…to continue the trial until the appropriate number of events has occurred”. In their letter to us they said that they reviewed “…progression free and overall survival and limited demographic and safety data available for the
aforementioned protocol.” This language tells us that they are following the guidelines outlined in their charter

I appreciate your work, should be an interesting couple of months ahead.