Replies to post #161013 on Cytodyn Inc (CYDY)

[bwolfy2002]

Sure, but that is not what you said. The FDA approves the trial protocol and the DSMC should provide guidance during the trials.

But they are tasked with a limited mandate of (and I’m not saying this right because this isn’t my job nor training) making sure people aren’t dying inordinately, that there is no chance of success, or that success can be practically guaranteed at that snapshot in time.

I could be wrong here but I do not believe it would be on them to consider dosing (and if the drug didn’t work they would just call it and end it). I have questions about their performance in CD12, but at the same time this stuff was thrown together by a broke pre-revenue biotech during a pandemic meaning that the agility required simply may not have been there as it might be for a more traditional or larger biotech, which explains the opportunity.

No underdog can be beholden to more than giving their best effort considering the circumstances. There is a risk/reward analysis that anyone should consider. If CYDY had a more traditional path, there’d be less questions about its outcomes meaning I would have less chance to be rewarded exponentially by the way in which I have deployed my capital.

It’s healthy to remember all this controversy is due to the fact that this is a high risk high reward investment and one can’t enjoy the rewards of that risk without expecting reciprocation from the other half of that risk wager. Alpha is coming up on the winning side of that duality more often that not generally speaking, while specifically stated this investment has outperformance of expectations in spades.

[CTMedic]

hotmeat,

I suppose you are technically correct. The FDA does not RUN the trials.

But but but but but but

TRIAL DESIGN is 100% the purview of the FDA.

Cytodyn, Merck, Pfizer, CTMedical (ok, I made the last one up, why not?), CANNOT run a trial without FDA approval.

Period.

So, returning to Doses 3 and 4, these were prohibited by limitations on the trial design. 100% FDA.

[Bill_ENG]

Currently Cytodyn has submitted new protocols for CD16. They are waiting on approval of the protocol from the FDA. This is where the FDA has the potential to exert influence and in the case of CD12 did.

EIND patients a year ago were getting more than 2 injections because they were at deaths door. They were getting what was needed. This is because the treating doctors were trying to save them and not having to follow a trial protocol.

[Pinseekr]

So if the DSMC says the drug is not working and “recommends” stopping the trial at mid point, Cytodyn could say nope it’s our trial we set it up and we are going to keep going even though you “recommend” we stop. Similarly, if the DSMC “recommended” you “modify” your trial (the very people who are instrumental in approval of your drug) you would say nope, no modifications we are going to do it our way. How about the last option, DSMC says don’t make any changes, you think the company would say forget those guys let’s add two more shots for next 14 days. Doesn’t fly, the DSMC DOES run the trial wether you believe it or not. For the DSMC to see the results after 14 days and not modify trial by adding 2 more shots for let’s say half of the trial group was just stupid. Very, very puzzling....