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Posted On: 06/24/2019 6:07:01 AM
Post# of 155015
So, 510(k) pre-submission meeting is on AUGUST 28.
FDA Grants Face-to-Face Meeting to Discuss CytoDyn’s 510(k) Application for ProstaGene™ Prognostic Test
VANCOUVER, Washington, June 24, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications today announced that the Center for Devices and Radiological Health (“CDRH”) of the U.S. Food and Drug Administration (“FDA”) has received CytoDyn’s previously announced submission of the 510(k) application for clearance of the ProstaGene™ Prognostic Test. CDRH has granted CytoDyn a face-to-face meeting to discuss the application on August 28, 2019. The ProstaGene™ Prognostic Test is intended for use in patients who have undergone a prostate biopsy and been found to have prostate cancer by the Gleason score.
“We are extremely grateful to the FDA for the timely action date on our recently filed 510(k) application for clearance of the ProstaGene™ Prognostic Test,” stated Dr. Nader Pourhassan, Ph.D., President and CEO of CytoDyn. “The ProstaGene™ Prognostic Test holds the potential to aid patients and physicians in better decision-making,” continued Dr. Pourhassan. “We eagerly look forward to working with the FDA to ensure that we continue to develop the ProstaGene™ Prognostic Test to the highest standards of the FDA and solidify our potential commercialization alternatives, including potentially value accretive partnerships,” concluded Dr. Pourhassan.
FDA Grants Face-to-Face Meeting to Discuss CytoDyn’s 510(k) Application for ProstaGene™ Prognostic Test
VANCOUVER, Washington, June 24, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications today announced that the Center for Devices and Radiological Health (“CDRH”) of the U.S. Food and Drug Administration (“FDA”) has received CytoDyn’s previously announced submission of the 510(k) application for clearance of the ProstaGene™ Prognostic Test. CDRH has granted CytoDyn a face-to-face meeting to discuss the application on August 28, 2019. The ProstaGene™ Prognostic Test is intended for use in patients who have undergone a prostate biopsy and been found to have prostate cancer by the Gleason score.
“We are extremely grateful to the FDA for the timely action date on our recently filed 510(k) application for clearance of the ProstaGene™ Prognostic Test,” stated Dr. Nader Pourhassan, Ph.D., President and CEO of CytoDyn. “The ProstaGene™ Prognostic Test holds the potential to aid patients and physicians in better decision-making,” continued Dr. Pourhassan. “We eagerly look forward to working with the FDA to ensure that we continue to develop the ProstaGene™ Prognostic Test to the highest standards of the FDA and solidify our potential commercialization alternatives, including potentially value accretive partnerships,” concluded Dr. Pourhassan.
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