“The HIV trials showed efficacy also.” Acco

“The HIV trials showed efficacy also.”

According to the PRs we’ve seen, and the presentation at ASM 2019, yes, 350mg demonstrated efficacy in the target HIV population. But that data has yet to lead to an approval for the 350mg dose and from what NP has said, the 350mg combo dose is all but dead in the U.S. So in the case of the 350mg trial, there appears to be no correlation between the FDA granting an open label extension and eventual approval for the same dose/indication.

To be clear, the PR said the FDA provided guidance on applying for an open label extension. CYDY still needs to file and get the application. approved. CYDY will develop a protocol and submit it, although the protocol will likely be based almost entirely off the IND filed earlier this year. There should be one update if permitted: weekly injections as needed up to X doses or until the patient expires or improves. They should not limit patients to two doses. The question that I cannot answer despite extensive research (on my phone and Xmas food tired): does an application for open label extension require efficacy data? If so, what data is CYDY planning on applying with?