Cytodyn Inc (CYDY)

[MJbiotech]

I'll chime in here with my professional opinion. I highly suggest that the author of the SA article (George Crist) familiarize himself with the FDA issued guidance on how to perform clinical trials for HIV drugs. It is clear to me from reading his article from today that he has not.

The guidance in entitled "Human Immunodeficiency Virus-1 Infection:Developing Antiretroviral Drugs for Treatment - Guidance for Industry"

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm355128.pdf

The CD02 trial design follows this guidance exactly as it should.

As per the guidance document (the patients in the CD02 trial would clearly be Group 2 patients):

When only one new drug is available for study in a clinical trial, a randomized placebo controlled superiority trial should be conducted where the primary endpoint is assessed at an early time point (see Figure 1). Longer term placebo-controlled comparisons have fallen out of
favor because continued use of the unmodified old (failed) regimen increases the risk of emergence of resistance to the investigational drug or the background drugs. In our recommended design, patients experiencing ongoing viral replication on their current regimen
and who need a new drug to construct a new viable regimen are continued on their current regimen, and randomized to add either placebo or the investigational drug (randomization to the investigational drug could be for one or more dose levels). The primary efficacy evaluation of investigational drug versus placebo occurs over a short duration (7 days to 2 weeks), before development of a significant risk for resistance to the new drug or additional resistance to the background drugs. After the placebo comparison, all patients can receive the investigational
drug (at one or various dose levels) added to a new background of approved drugs that are optimized by use of resistance testing.

I highly recommend everyone to check out page 15-17 of said guidance document, as there is a trial design flow chart in there that exactly matches the design of the CD02 trial.

Its also important to note that the FDA approved the CD02 trial design as a pivotal trial.

IMO, the SA article is nonsense.