Cytodyn Inc (CYDY)

[ClosetInvestor]

"..but the FDA came up with a very lame excuse to not give pro 140 a BTD.."

The "lame excuse" is actually a legitimate reason. BTD is a big achievement and is not handed out like candy by the FDA. Yes, PRO 140 has shown progress but not in a clinical trial as a teatment for HIV-1 Infection in Treatment-Experienced Patients with Virologic Failure. That's a fact and that's why the FDA rejected the application. The company should've never PRed the fact that they applied for BTD because then they have to explain why they got denied. They learned their lesson. The conspiracy game is old and lacks facts.

Below is the company's comments on the BYD issue.

"However, the FDA indicated that CytoDyn’s previous studies were not in the specific patient population that the Breakthrough Designation for PRO 140 was applied for. Therefore, CytoDyn needs data from that specific population that the Breakthrough Designation was applied for in order to be granted that Breakthrough Designation