Cytodyn Inc (CYDY)

[Borel Fields]

The Mexican cohort might be incorporated in US study. Or conversely, Mexico will evaluate data from a US study interim report augmented by data on their own population to support local approval.

Almost all of these studies are global. Given the protocol is parallel to the US version, it seems something the FDA might recognize. Mexico could certainly re-calculate a pooled p-value.

If stat significance is marginal on the 51-patient look-in, my guess is that the FDA would simply roll to a second look-in, perhaps at patient 125-150, or maybe a date certain - say July 20 to give Mexico a chance to contribute.

S/C enrollment is ongoing - 51 was "before June 1st." What's it up to now?