Replies to post #50087 on Cytodyn Inc (CYDY)

[Grip it and Sip It]

Something we agree on! The FDA has been no friend of CYDY, and it’s the patients that pay the cost!

This current administration is de-regulating many areas. This should be one that allows the FDA greater latitude to get ground-breaking drugs to market when they have no side effects.

Grip

[MrGuru]

Ohm,

Exactly. The point is that FDA could have EASILY approved the 525 mg dosage with the condition of post-approval optimization (it happens all the time).

Look at DVAX approval of Heplisav-B (Hepatitis B) that demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. They required lots of post-approval follow up, but approved the vaccine in spite of all the AE's.

FDA could have approved Leronlimab and told the company: Follow up your 525mg patients and launch a second trial with higher dosage with naïve and/or migrated patients.

This, much easier granted the demonstrated safety of the drug (0 SAE's), and, even better with CTC counts and/or occupancy tests.

But, no. They decided to subject an economically unstable company to the burden of a significant delay just to keep them happy.

With leronlimab the FDA pisses around while people die and they should be held accountable for that.

You are absolutely right. Couldn't have said it better.