Replies to post #5190 on Cytodyn Inc (CYDY)

[chumppunk]

Amatuer, Goldenisla- With the clock starting at July 21, any time they could get a response. But there's a big play ground to invest in. Timing is most crucial. CYDY is my sand box for now.
Chump

CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140 of Treatment-Naïve HIV Patients

60-PATIENT TWO-WEEK STUDY ALSO CARRIES POSSIBILITIES OF BREAKTHROUGH THERAPY DESIGNATION

VANCOUVER, Washington, July 21, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen. The generation of these assay results typically takes approximately two weeks.

The basis for CytoDyn’s request is stated below in an edited excerpt from the Company’s recent letter to the FDA:

The estimated incidence of new HIV infections in the U.S. is just under 50,000 per year, an estimated 47,129, 49,273 and 44,073 people were diagnosed with HIV infection in the U.S. in [2013, 2014 and 2015, respectively] (Centers for Disease Control and Prevention (CDC), 2016). CCR5-tropic strains are found in about 90% of treatment-naïve patients (Hoffmann, 2007; Brumme et al., 2005; Moyle et al., 2005; Mueller et al., 2007). PRO 140 is a unique product dissimilar from currently available treatments for HIV-1 Infection. Unlike HAART, PRO140 treatment can be initiated immediately after HIV diagnosis, while waiting for genotypic drug resistance assay results to construct an optimal antiviral regimen. Therefore, we would like to request orphan drug designation of PRO 140 for HIV-1 infection in treatment-naïve adults while waiting for drug resistance assay results to construct HAART regimen.
On July 18, CytoDyn submitted a protocol to the FDA for a Phase 2b clinical trial with PRO 140 for treatment-naïve HIV adults and the Company expects to file for a breakthrough therapy designation upon receipt of successful results for the first few patients. The Company believes that should the treatment-naïve trial be successful, it may position PRO 140 for a much faster path to approval compared with the Company’s two other Phase 3 trials with PRO 140.