Replies to post #21855 on Cytodyn Inc (CYDY)

[trding]

Thanks. One other interesting note to me, Cydy requested 2 MDR originally and the FDA denied it limiting it to 3 MDR until the latest meeting where they allowed 2 MDR. The 3 MDR market is much smaller set, one reason for the greater length of filling the trial. The following though makes me believe the FDA may allow expansion. Maybe one of the reasons they are requiring much more for Pro 140 Combo than they did for Ibalizumab, not sure.



But look at Trogarzo aka Ibalizumab.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm

The safety and efficacy of Trogarzo were evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs. Many of the participants had previously been treated with 10 or more antiretroviral drugs. The majority of participants experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their failing antiretroviral regimens. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression.


The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations. Trogarzo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

https://www.cytodyn.com/media/press-releases/detail/258/potential-for-cytodyns-pro-140-for-treating-hiv-patients

Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that its application for Orphan Drug Designation (ODD) was not granted by the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) because PRO 140 appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested.