Cel Sci Corporation (CVM)

[Biobonic]

From the Red*it chat

In early 2016 the annual report to the regulators showed the overall death rate in the study was lower than expected. That is why we felt we needed to add more patients. The request for more patients was withdrawn in early 2017 because the 2017 annual report filed early in the year showed that the overall death rate had caught up to the expected death rate. Therefore the increase in patients was no longer needed.

If one were to investigate what the 'annual report' was and how much documentation there is in it, that the sponsor puts together, and how much data from the IDMC (different entity and reports than the annual) gets sent to the sponsor, one could develop a confidential outlook.

FDA IND annual reports briefing
Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees

Here is a tidbit of info:
In early 2016 the annual report to the regulators showed the overall death rate in the study...

Death rate in annual report, and the sponsor (Cel Sci) has access to this data?
Well, it's the sponsors responsibility to put it together...