Cytodyn Inc (CYDY)

[fred198484]

If you really think the FDA would approve before the trial is complete, you are taking way too much risk. That just never happens.

In theory, CYDY does not yet know the PE data since the trial has not yet ended and has therefore not been unblinded. But I am sure they have some indications about how it is going. The PR expressed optimism about the trial results based on the phase II trial outcome but perhaps that was meant to signal that we should not be freaked out by the need to go talk to the FDA at this late stage about the current phase III combo trial. There is certainly a possibility the reason for wanting to talk to the FDA is positive but long experience with such things causes me to assume a more negative scenario. Hopefully, I am wrong.

One of the problems with the combo trial is that they do not have a large data set. If the results the current combo trial are good but not great, the FDA may require another phase III combo trial as 2 phase III's are the norm.

The mono is a larger trial but it is going to be a while until we get those results. And the company needs to figure out a way to financially survive until then. That is why the combo trial results are a binary event even though combo is not likely going to be a big deal for the company from a revenue perspective. If the combo results are great, they can raise the needed money. If not, then what?

Great combo results are not going to convince any large pharma to pay a fortune for the mono opportunity. No one knows yet if PRO 140 will work in monotherapy and we will not know until the mono trial is completed. And, in order to compete in first line therapy, one has to imagine the FDA will require a second large mono phase III. If the first mono phase III is good, they may get a partner or taken over but it is hard to see any big pharma paying a huge amount anytime before the first mono phase III results are available.