Cytodyn Inc (CYDY)

[Amatuer17]

Wait for completion of 700 mg dosing and results - that will take you to end of the year minimum.
Add 2 months to FDA meeting to discuss next steps - if they agree to use limited data from current trial that has 3 dosing (350,525,700) and agree for filing supplementary BLA, they maybe able to file it in Q4-2019 and get approval in 2020 - I do not consider this as possible as the P3 trial was investigational and not pivotal and had 3 levels of dosing.

My view is - depending on safety of 700 mg dose, FDA will ask for a new pivotal trial of at least 200 patients with 700 mg dosing - 48 weeks duration.

This can start in Q1-Q2 2019 and will take 6-8 months of enrollment and then 12 months to complete trials and topline results. Then full results, BLA, 6-9 months approval. You will go into 2021 or later.