Cytodyn Inc (CYDY)

[finesand]

Prelim take on Rolling BLA

- FDA seems to wants 24 Weeks SAFETY DATA complete before reviewing it
- CYDY says they have it until EOY 2019, Starting BLA Review Timer
- For all other things missing, the rolling BLA will accept later submission in ongoing review

That is positive, because indicates that Mono enrollment is better than we thought for around 240 patients for safety.

Then we finally got the blessing from the FDA and one Fast Track privilege already: Rolling BLA

With the next privilege Priority Review (also a rumor from same source) we should be done until June 2019, end of 2Q19.

While this is not the best outcome of the FDA meeting, it is sort of 80% of the best. Surely not the worst (o8>

Meaning in around mid 2019 we have a full value Combo drug and stock is traded now at .. err .. 91% discount.