Right. We all need to be polite. What China doe
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Posted On: 03/18/2020 12:42:56 PM
Right. We all need to be polite.
What China does testing wise is up to them per Joe:
"Second paragraph this goes direct to the no ANIMAL Testing - however if the Chinese don’t wanna listen or take our advice or follow FDA guidance from here that’s their business not out since they are the ones doing the trial work after we deliver the vaccine."
-One of the benefits of a peptide-based vaccine is that it is more rapidly adaptable to newly
emerging strains of coronaviruses than the current egg-based vaccine production. Our
peptide vaccine is manufactured by an entirely synthetic process, which enables the
synthesis of material for 100s of millions of doses in a few months. The peptide vaccine
is manufactured by a Good Manufacturing Practices (GMP) contract manufacturing facility
using protected amino acids of non-animal or plant origin. It is produced by solid-phase
peptide synthesis.
The safety of Ii-Key Peptide vaccines has been demonstrated in animal toxicology and
human clinical trials. Based on the wealth of non-clinical and clinical data demonstrating
the generally recognized safety of peptide vaccines, the FDA has allowed NuGenerex
Immuno-Oncology to proceed directly to human clinical trials with the AE37 Ii-KeyHER2/neu Peptide Vaccine.
What China does testing wise is up to them per Joe:
"Second paragraph this goes direct to the no ANIMAL Testing - however if the Chinese don’t wanna listen or take our advice or follow FDA guidance from here that’s their business not out since they are the ones doing the trial work after we deliver the vaccine."
-One of the benefits of a peptide-based vaccine is that it is more rapidly adaptable to newly
emerging strains of coronaviruses than the current egg-based vaccine production. Our
peptide vaccine is manufactured by an entirely synthetic process, which enables the
synthesis of material for 100s of millions of doses in a few months. The peptide vaccine
is manufactured by a Good Manufacturing Practices (GMP) contract manufacturing facility
using protected amino acids of non-animal or plant origin. It is produced by solid-phase
peptide synthesis.
The safety of Ii-Key Peptide vaccines has been demonstrated in animal toxicology and
human clinical trials. Based on the wealth of non-clinical and clinical data demonstrating
the generally recognized safety of peptide vaccines, the FDA has allowed NuGenerex
Immuno-Oncology to proceed directly to human clinical trials with the AE37 Ii-KeyHER2/neu Peptide Vaccine.
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