Manufacturing should be complete by mid-end of Mar
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Posted On: 03/06/2021 7:31:13 PM
Re: SeekingAlfa #27254
Manufacturing should be complete by mid-end of March. The IND app should be reviewed quickly. I recall Generex pointed out how good the response by the FDA was regarding the pre-IND. I believe the FDA agreed with the entire plan other than requesting the immunogenicity study. The study revealed we have a great iGg antibody response.
Why would we miss the market in the US? Our antibody response is robust, we'll give long term immunity and we'll have perhaps the best safety profile. If we wind up being superior, there is no reason we won't be part of the equation this year. Perhaps the go to choice. Maybe not for most peoples first series but if Covid needs an annual vaccine we will have a place for the next round. Of course we may be chosen as a booster for the others to give longer immunity. Not to mention we may already be set up to handle the variants and can add epitopes if not.
Room temperature is another plus. Ease of manufacturing millions if not billions of doses rapidly is huge.
We haven't paid much attention to Dr Jonathan Davis, who is on the NGIO SAB. Scientist/doc's of his caliber are hard to come by and GNBT/NGIO have him on the team. His bio:
Dr. Jonathan Davis, MD is Vice-Chair of Pediatrics and Chief of Newborn Medicine at Tufts Children’s Hospital and Professor of Pediatrics at Tufts University School of Medicine. He is also Chair of the Neonatal Advisory Committee in the Office of the Commissioner at FDA, Director of the International Neonatal Consortium (INC) through FDA, the European Medicines Agency, and the Critical Path Institute, and Associate Director of the Tufts Clinical and Translational Science Institute. Dr. Davis’ research has focused on neonatal drug development and he is currently funded by NIH and FDA to develop better biomarkers and outcome measures for clinical trials and new and existing therapeutics to improve neonatal outcome. He is Co-PI of a recent $8M NIH award to Tufts to fund a national clinical trial studying the integration of targeted genomic sequencing into neonatal diagnosis and care and a $5M FDA award to generate real world evidence for neonatal clinical trials.
I will be thrilled with an IND app by early April.
Why would we miss the market in the US? Our antibody response is robust, we'll give long term immunity and we'll have perhaps the best safety profile. If we wind up being superior, there is no reason we won't be part of the equation this year. Perhaps the go to choice. Maybe not for most peoples first series but if Covid needs an annual vaccine we will have a place for the next round. Of course we may be chosen as a booster for the others to give longer immunity. Not to mention we may already be set up to handle the variants and can add epitopes if not.
Room temperature is another plus. Ease of manufacturing millions if not billions of doses rapidly is huge.
We haven't paid much attention to Dr Jonathan Davis, who is on the NGIO SAB. Scientist/doc's of his caliber are hard to come by and GNBT/NGIO have him on the team. His bio:
Dr. Jonathan Davis, MD is Vice-Chair of Pediatrics and Chief of Newborn Medicine at Tufts Children’s Hospital and Professor of Pediatrics at Tufts University School of Medicine. He is also Chair of the Neonatal Advisory Committee in the Office of the Commissioner at FDA, Director of the International Neonatal Consortium (INC) through FDA, the European Medicines Agency, and the Critical Path Institute, and Associate Director of the Tufts Clinical and Translational Science Institute. Dr. Davis’ research has focused on neonatal drug development and he is currently funded by NIH and FDA to develop better biomarkers and outcome measures for clinical trials and new and existing therapeutics to improve neonatal outcome. He is Co-PI of a recent $8M NIH award to Tufts to fund a national clinical trial studying the integration of targeted genomic sequencing into neonatal diagnosis and care and a $5M FDA award to generate real world evidence for neonatal clinical trials.
I will be thrilled with an IND app by early April.
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