You are way out-of-date, JPValas. Dr. Janet Woo
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Posted On: 11/27/2020 2:56:36 PM
You are way out-of-date, JPValas.
Dr. Janet Woodcock was the head of CDER (Center for Drug Evaluation and Research) at the FDA for 17 years. CDER is where the heavy lifting is done for drug approvals after a drug's trials are completed successfully. They ask the hard questions about manufacturing, distribution, safety in the field and marketing. If CDER doesn't get the right answers, a drug will not be approved for sale.
But Woodcock was assigned to join the OWS program for Therapeutics and MABs discovery and development on May 15, 2020.
Woodcock "is leading OWS’s effort on therapeutics development. Woodcock said, “Even with success, some people will not respond to vaccines, and some people will not get vaccinated. So, therapeutics will always be needed.”"
OWS and the National Institutes of Health developed two master protocols for COVID-19 monoclonal antibody clinical trials. One will test the use of monoclonal antibodies in the outpatient setting, and another is for inpatient use.
Easy to read Power Point presentation of OWS mission as Woodcock sees it -
https://mod.isirv.org/repository/avg_2020/Janet_Woodcock.pdf
She knows about Cytodyn and Leronlimab and is keeping track of their progress but is letting Cytodyn pursue things their way. She has offered help with large scale rollout if Cytodyn asks. This has made me rest much easier.
She is all about MAB development to fight Covid but I don't think she realizes what we have in Leronlimab. I think she still thinks of MABs as something to target the virus and as immunomodulators but not something that can bring about immune system homeostasis. This is what so excited Patterson.
As he said in his TED talk, it was a real game-changer to get the immune system to fight cancer. If you have an immune system that is correctly balance among all its components, it can do much more than fight cancer and a lot of medicine then becomes a matter of tuning the immune system to meet each challenge.
If it is weak in some area, you try to give it a boost; if it is too strong in some area, you immunomodulate.
This keeps all immune components in the right places, in the right strengths, at the right times. It seems that as we age, depending on our individual health histories, the immune system can get out of whack. Leronlimab seems to give the immune system a tune-up.
Cytodyn will succeed if it can prove the wisdom of this approach.
Dr. Janet Woodcock was the head of CDER (Center for Drug Evaluation and Research) at the FDA for 17 years. CDER is where the heavy lifting is done for drug approvals after a drug's trials are completed successfully. They ask the hard questions about manufacturing, distribution, safety in the field and marketing. If CDER doesn't get the right answers, a drug will not be approved for sale.
But Woodcock was assigned to join the OWS program for Therapeutics and MABs discovery and development on May 15, 2020.
Woodcock "is leading OWS’s effort on therapeutics development. Woodcock said, “Even with success, some people will not respond to vaccines, and some people will not get vaccinated. So, therapeutics will always be needed.”"
OWS and the National Institutes of Health developed two master protocols for COVID-19 monoclonal antibody clinical trials. One will test the use of monoclonal antibodies in the outpatient setting, and another is for inpatient use.
Easy to read Power Point presentation of OWS mission as Woodcock sees it -
https://mod.isirv.org/repository/avg_2020/Janet_Woodcock.pdf
She knows about Cytodyn and Leronlimab and is keeping track of their progress but is letting Cytodyn pursue things their way. She has offered help with large scale rollout if Cytodyn asks. This has made me rest much easier.
She is all about MAB development to fight Covid but I don't think she realizes what we have in Leronlimab. I think she still thinks of MABs as something to target the virus and as immunomodulators but not something that can bring about immune system homeostasis. This is what so excited Patterson.
As he said in his TED talk, it was a real game-changer to get the immune system to fight cancer. If you have an immune system that is correctly balance among all its components, it can do much more than fight cancer and a lot of medicine then becomes a matter of tuning the immune system to meet each challenge.
If it is weak in some area, you try to give it a boost; if it is too strong in some area, you immunomodulate.
This keeps all immune components in the right places, in the right strengths, at the right times. It seems that as we age, depending on our individual health histories, the immune system can get out of whack. Leronlimab seems to give the immune system a tune-up.
Cytodyn will succeed if it can prove the wisdom of this approach.
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