FDA Grants Face-to-Face Meeting to Discuss CytoDyn’s 510(k) Application for ProstaGene™ Prognostic Test
CYTODYN INC (CYDY)
NASDAQ:AMEX Investor Relations:
ir.cytodyn.com
Company Research
Source: GlobeNewswire
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.
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News
- CytoDyn Announces FDA Has Lifted Clinical Hold [Yahoo! Finance]Yahoo! Finance
- CytoDyn Announces FDA Has Lifted Clinical HoldGlobeNewswire
- CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in Glioblastoma [Yahoo! Finance]Yahoo! Finance
- CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in GlioblastomaGlobeNewswire
- CytoDyn Appoints Jacob Lalezari M.D. as CEO, Mitchell Cohen as Interim CFO [Yahoo! Finance]Yahoo! Finance
CYDY
Sec Filings
- 3/8/24 - Form 4
- 3/1/24 - Form 424B3
- 3/1/24 - Form 424B3
- CYDY's page on the SEC website