Replies to post #34872 on Cytodyn Inc (CYDY)

[finesand]

black - yes. But we expect a little bit more from FDA now: Reusing more of the patient population.

We know for sure they are screening 40 new pts for 700mg mono, that's for the new trial.

We will see how their dialog goes w/ FDA and 700mg mono data.
In the end it is more about statistics and what the FDA accepts, the data of many 700mg pts already exists.
NP was unsure about this issue in previous CC.
Now that FDA likes the 700mg results .. we will see.

Safety data is across indications, of course.
RP also mentioned this in one of his earlier CCR5 Cancer talks, using a CCR5 inhibitor already approved for HIV-1 w/ given safety.

The real bombshell was added at the end of the PR, the partnership financing pre-approval.
Until today, CYDY only vaguely talked about it.
Now they have written it out quite detailed. Distributors and manufactures chipping in, bridging financing until approval.
This is possible b/c Combo (and IMHO Mono) is derisked now.

Note aside, in our model we also reference a study about given discounts within a financial model for each stage of a drug.

Valuation discount for todays price, Early-Stage 70%, Mid-Stage 40%, Late-Stage 30% NPV Discount Rate – 80% intervals www.avance.ch/avance_biostrat_discount_survey.pdf

Combo and Mono are now considered late-stage, where Combo already has entered BLA w/ one leg. Only financing has hindered company to fully apply. This also seemingly will be resolved with the partnership financing model.

All of this is reason I am so excited today.

Financing secured?!