The wait may also be due to the FDA waiting on Brazil results and already has NASH 700, mTNBC and is getting Amarex data. They know Amarex screwed us and now the Brazil results will give them a new MAB.

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Finally, in early March, Amarex executed a rush submission of an Investigational New Drug (IND) amendment to add COVID-19 as a new indication under an existing IND owned by the company CytoDyn for their monoclonal antibody product, leronlimab. The product is currently being tested for HIV infection and has the potential to modulate the life threatening ‘cytokine storm’ sometimes seen in COVID-19 patients. CytoDyn received rapid approval from the FDA for emergency treatment of an initial cohort of seven extremely ill COVID-19 patients. On March 27, 2020, CytoDyn released initial positive results in the first four patients treated, having seen a reduction of the hyper-immune response three days following treatment initiation.

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