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Posted On: 10/08/2021 2:15:19 PM
Post# of 36564
Under scheduling ... I'm beginning to believe that GNBT/NGIO finished the medium scale production between 4/4 and 6/16 where dilution drops and is in a holding pattern while SEC/FDA issues resolve (per Krilac). I also think the 5/5 PR was a message that they were preparing to hand over material so that China trials could begin. So did task 4 start in China and how do we find out?
4/12: Information to FDA in advance of IND submission
5/5: Puts out clarification that China will provide data to NGIO ... given that China will work independently
4/4 – 6/16: Share dilution dropped by 50%
Task 4: Manufacture GMP Ii-Key-SARS-CoV-2 Vaccine Manufacture medium-scale, GMP-grade multivalent Ii-Key-SARS-CoV-2 Peptide Vaccine for Phase I and Phase II human clinical trials.
Task 5: Phase I and Phase II Human Clinical Trials (China and the U.S. proceed simultaneously) Early stage clinical trials to evaluate the safety and dose of the final Ii-Key-SARS-Co V-2 Peptide Vaccine in health adults (18 - 55 years old).
4/12: Information to FDA in advance of IND submission
5/5: Puts out clarification that China will provide data to NGIO ... given that China will work independently
4/4 – 6/16: Share dilution dropped by 50%
Task 4: Manufacture GMP Ii-Key-SARS-CoV-2 Vaccine Manufacture medium-scale, GMP-grade multivalent Ii-Key-SARS-CoV-2 Peptide Vaccine for Phase I and Phase II human clinical trials.
Task 5: Phase I and Phase II Human Clinical Trials (China and the U.S. proceed simultaneously) Early stage clinical trials to evaluate the safety and dose of the final Ii-Key-SARS-Co V-2 Peptide Vaccine in health adults (18 - 55 years old).
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