Replies to post #34866 on Cytodyn Inc (CYDY)

[finesand]

(edited) It is my understanding that the patients switching to 700mg in the monotherapy trial will do that for the purpose of avoiding delays not only for the Combo BLA, but also for the pivotal Mono trial. Hence the mentioned 40 pts currently in screening for Mono as well. We read it as they all will provide data also for the pivotal Mono data set, which would avoid further delays here as well. FDA surely has been impressed by the 700mg data.

EDIT: The initial BLA filing incl safety is good for Combo initially and will speed up the subsequent indications: Mono and TNBC. Safety data will be used for all across.

This was the first follow-up meeting since its June 2018 pre-BLA meeting regarding the Company’s planned submission of its BLA and the positive interim data of its 700 mg monotherapy trial.

The FDA recognized that the higher dosage of 700 mg in the monotherapy trial had a much higher response rate than the 350 mg dose used in the combination therapy trial. In order to avoid a long delay in the BLA filing, the FDA agreed to accept safety data from 100 patients in the monotherapy trial with the 700 mg dose, which enables the BLA submission for the combination therapy to use 700 mg instead of the original 350 mg dose.

CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.