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Posted On: 06/25/2021 1:26:06 PM
Post# of 36541
Ok, so we already know the GMP is completed, but I was a little confused by this part in the PR. Can they submit IND before the “lot release scheduled for July” mentioned below? Also, are the stability tests separate from this? I just found the wording in this paragraph to be unclear.
The final lot release of the COVID-19 vaccine from the manufacturer for use in clinical trials is scheduled for July. Stability studies are ongoing to support the IND, which is currently being compiled for submission to FDA. Contingent on FDA approval and the receipt of financing the final vaccine manufacturing process is commercial ready using a lyophilization method that produces a stable, powdered Ii-Key-SARS-CoV-2 vaccine that can potentially be shipped and stored at room temperature, providing a substantial commercial advantage.
The final lot release of the COVID-19 vaccine from the manufacturer for use in clinical trials is scheduled for July. Stability studies are ongoing to support the IND, which is currently being compiled for submission to FDA. Contingent on FDA approval and the receipt of financing the final vaccine manufacturing process is commercial ready using a lyophilization method that produces a stable, powdered Ii-Key-SARS-CoV-2 vaccine that can potentially be shipped and stored at room temperature, providing a substantial commercial advantage.
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