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Posted On: 04/08/2020 10:01:36 AM
Post# of 153940
Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA
Amarex Clinical Research work for CytoDyn in the UK brought up this impressive press release from them for 3 different client FDA submissions that I had not seen before.
https://www.globenewswire.com/news-release/20...e-FDA.html
The submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an Emergency Use Authorization for a PCR-based IVD for COIVD-19 detection
April 02, 2020 11:22 ET | Source: NSF International
Ann Arbor, Mich., USA, April 02, 2020 (GLOBE NEWSWIRE) -- In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV infection, and oncology indications, and has the potential to modulate the “cytokine storm” sometimes seen in COVID-19 patients. A “cytokine storm” is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.
Amarex Clinical Research work for CytoDyn in the UK brought up this impressive press release from them for 3 different client FDA submissions that I had not seen before.
https://www.globenewswire.com/news-release/20...e-FDA.html
The submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an Emergency Use Authorization for a PCR-based IVD for COIVD-19 detection
April 02, 2020 11:22 ET | Source: NSF International
Ann Arbor, Mich., USA, April 02, 2020 (GLOBE NEWSWIRE) -- In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV infection, and oncology indications, and has the potential to modulate the “cytokine storm” sometimes seen in COVID-19 patients. A “cytokine storm” is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.
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