Cytodyn Inc (CYDY)

[fred198484]

Very interesting. Did they just go ahead and make that change themselves so they could actually fill up the trial? Or did the FDA agree to it. Is this why they need to talk to the FDA about how they are going to analyze the data? It was kind of ridiculous for the Maraviroc requirement to be there in the first place and I would think the FDA should be able to see that.

Also, they took away the requirement for there to be one fully active approved drug and just made it one fully active drug which likely means they can use Ibalizumab and Fostemsavir if the patient is resistant to all the standard HIV drugs.

It will be interesting to find out what exactly happened here. Di they go to the FDA and request these changes or did they decide to make them and ask for forgiveness later. The changes make sense so the FDA should agree. But it also will complicate the data analysis since some patients will have been in the test under the original set of conditions and some under the latter set of conditions.

It also may be why the test has not been officially closed yet. The FDA may want them to recruit 30 patients under the new set of conditions. SO this announcement likely explains a lot about the weirdness of the last 2 PR's.