Cytodyn Inc (CYDY)

[Saltz]

I think we missed the actual meaning and outcome of the IDMC Interim Combo PR.

“Independent Data Monitoring Committee Recommends Continuation of CytoDyn’s PRO 140 Pivotal Combination Therapy Trial as Planned Without Modifications to Achieve Primary Endpoint”

The fact is there were only three conclusions that could have been reached by the IDMC.

1- Discontinue Trial
2- Amend the Trial
3- Continue as is

Pro-140 got the best result that was possible and I believe N=50 Combo PE is a done deal they just can’t say so because that would be out of line with the FDA. The FDA said 50 patients so they get 50 regardless of the N=40 Interim Combo PE Data.

Terminating the trial at 40 patients was not an option regardless of how convincing the data was to the IDMC. The company was never given the green light to unblind other than to the independent Doctors. The above PR was the max the company could say without crossing the line with the FDA which gets final say.

This is a big event but it does not come across as one because of the procedure that has to be adhered to with respect to the FDA. I think the company thought this was going to be a major news event but because there hands were tied in terms of what they could say it was not.

The issue as always is time. How long until they can get 50 patients and end this charade. When they have the 50th patient enrolled it will take five more weeks to PR N=50 Combo PE.

The good news is the company now knows they have a drug that works in Combo and has had zero SAE’s to date other than a couple of site injection issues. So IMO Tony is diligently working on the BLA checklist. His expertise with Gilead was building out the manufacturing platform for new drugs. This needs to be done to increase valuation for a buy out.

I think we can expect a R/S and uplist when N=50 Combo PE is announced. The Interim Mono data will be the first news to come after the uplist. It’s bye bye OTC, hello Nasdaq some time in Q1 2018. Time to open this science up to the investment world.