Replies to post #199446 on Cytodyn Inc (CYDY)

[Bill_ENG]

" Who needs Covid ? "

A company with no revenue on the horizon for the next two years could probably use a pathway to make revenue and a pathway to use up expiring Leronlimab product.

LH is a phase 2, not even looking at starting much less completing a phase 3 till 2023, completion and BLA 2024 ?

Nash - Phase 3 maybe in 2022 completing in 2023. BLA ? 2023 or 2024 ?

HIV ? Let's see if they can submit a complete BLA at all, then see if it is accepted by the FDA then at end of 2022 maybe I'd lucky approved. That's combo therapy, not even mono therapy so mono therapy in 2024 ?

Covid was the only chance of saving this company from bankruptcy by cash injection and using up existing Leronlimab before it's worthless.

Jmo

[HyGro]

The Secondary endpoint was the cT1 metric that the company has touted aggressively in the last press release. The claim was it was an analogue for the fibrosis and inflammation. This press release made two statements that the cT1 results were significantly better than placebo. One problem -- IT WASN'T. The press release also included the follow

"Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1." Which means that Leronlimab did NOT meet its secondary trial endpoint (only near). This after two times saying they did.

The primary endpoint not only needs to be significant, it has to be competitive with the leading NASH candidates. The prior press said it was 16-20% fat reduction which maybe significant vs. placebo but be mediocre against leading competitor levels.

The reason Recknor did an open label trial is because of the risks of the Amarex lawsuit and not being able to access the blinded trial. That has been resolved and he clearly has the double blind trial data too but is not releasing the 700 mg for some reason. You can't get the placebo data unless you unblind the 700 mg and the placebo at the same time.

So we have misrepresented secondary metric (cT1), an primary metric that they report a statistically significant but won't release the actual data. They have the placebo data but won't release the 700 mg that was analyzed when the placebo data was. Jury is still out until real data is released -- question, why wouldn't the company release the actual data??