Replies to post #11698 on Cytodyn Inc (CYDY)

[BlackDoggie]

Completely agree that all that matters at the end of the day is whether or not the trials hit the primary endpoints. That said, I consider it prudent to keep monitoring that "noise" up until then to - objectively - determine whether it provides any value in assessing the probability of hitting endpoints. Otherwise, it's kind of like having the ability to bet on a football game at any point during the game, but choosing to place your bet prior to the game and then not watching.

Ok, maybe a bad example given that the last meaningful football game would have resulted in about 99% of folks taking the wrong bet by halftime! But the point remains that meaningful information can be gained from markets, otherwise nobody would watch the markets. Any information is money.

Here's to hoping for good news on those PE's so that the rest of it is, indeed, noise.

[Saltz]

The bar is set so low in the Adjunct Trial it is nearly impossible that PE will not be achieved given results up to this point. I think the duration of enrollment is what has most here concerned. That is simply a lack of understanding about the complexity of the protocol for the study and the lengthily communication with the FDA to reduce number of patients. Once enrollment is completed PE will be achieved one week later so that can be any day or worst case we slip into April.

The wild card is BTD. My experience is the FDA generally takes the entire 60 days regardless of which way they are leaning. Time generally provides more data for the FDA to base their decision on. It is impossible to know what the FDA is thinking and they can hang their hat on any minor detail to reject. Generally it is a safety issue combined with a lack efficacy-Pro-140 IMO easily passes all the criteria. Many on this board downplay the significance of BTD and while it is not a deal breaker it is like saying no to upgrading to a Ferrari when you are currently driving a Prius...your going to finish the race much later.

If we hit both catalysts the stage will be set for a possible end game this year. Final data P3 Adjunct and interim data P3 Mono will tell the story if we make it that far before being bought out. So we are on schedule and no news is not bad news. A very important month that will lead to even more important months- it's only going to get more exciting or intense depending on your mindset.