Cytodyn Inc (CYDY)

[Saltz]

Sammie, you are correct the FDA is responsible for issuing an EUA not the DSMC. My understanding is that the DSMC makes recommendations to the FDA regarding their findings at interim. The FDA then makes final decision.

A Data Safety Monitoring Board or Committee (DSMB or DSMC) consists of experts in the field of research tasked with reviewing data integrity and safety.

A DSMB/DSMC is mandatory:

* If the trial is evaluating mortality or another major endpoint, such that inferiority of one treatment arm has safety as well as effectiveness implications
* If it would ethically be important for the trial to stop early if the primary question addressed has been definitively answered, even if secondary questions or complete safety information were not yet fully addressed

Satisfying The EUA Criteria
The FDA has established four broad criteria that must be met in order to participate in the EUA program and be granted an EUA:
1. Presence of a serious or life-threatening condition
2. Evidence of effectiveness
3. Risk-benefit analysis (safety)
4. No other alternatives to address the life-threatening condition