Cytodyn Inc (CYDY)

[fred198484]

The Clinincaltrials.gov site was updated again yesterday. I am not sure what was updated other than the date for the PE and trial completion. Now, it says the PE will be in October and the trial will be completed in April 2018.

The press release today does clear up some of the open questions. I suspect the change in the protocol to exclude Maraviroc and include the use of non-approved drugs (read Ibalizumab and Fostemsavir) in the trial is what has caused the need for the study to remain open and recruiting in order to get a clean data set for the FDA to be able to review for the BLA.

This delay likely means approval does not happen until mid 2019. But there remains uncertainty about what exactly is going on between CYDY and the FDA over PRO 140.