Cytodyn Inc (CYDY)

[Chuckles759]

Reading through the article posted here:

https://talkmarkets.com/content/stocks--equities/hiv-cure-challenger-cytodyn-takes-on-the-gilead-sciences?post=267711

A cure for HIV has been sought after for decades, and recent studies are demonstrating a greater understanding of CCR5 and the crucial role it plays in disease pathogenesis. This study if successful would be a huge datapoint to support label extension of leronlimab. In all likelihood they would get a BTD. Right now the company has the potential for 3 BTD’s in metastatic Triple Negative Breast Cancer, metastatic cancer, and COVID-19. CytoDyn is expecting its PDUFA date by July 11th. It filed its BLA in April and is widely expected to receive a PDUFA date in August or September because it has fast track and rolling review. The market reaction to this news was underwhelming and clouded by the spectre of fake news and threats of attorney litigation. Gilead has been very quiet about velastamod so it’s conceivable that a leronlimab approval in HIV combination therapy could easily upset the HIV cure leaderboard putting itself on top.

(emphasis mine)

I sent the article's author a message asking how he knows that the HIV-1 BLA has been designated "fast track". I've not seen that announcement on FDA's website yet. As I understand the CDER process, that would only be communicated to CytoDyn who would understandably make it a PR.