Monday, February 22, 2021 12:47:19 PM
Thanks Misiu and Rockleo for the quick responses.
The bullet point that grabbed my attention was on page 6.
• FDA strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the risk of losing activity against emergent variants. FDA encourages collaborations between sponsors of individual monoclonal antibody products to address this unmet medical need.
I was thinking that perhaps the FDA wants Cytodyn to partner up with Regeneron or Eli Lily for manufacturing to meet supply.
Thanks again,
The bullet point that grabbed my attention was on page 6.
• FDA strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the risk of losing activity against emergent variants. FDA encourages collaborations between sponsors of individual monoclonal antibody products to address this unmet medical need.
I was thinking that perhaps the FDA wants Cytodyn to partner up with Regeneron or Eli Lily for manufacturing to meet supply.
Thanks again,
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