(Total Views: 352)
Posted On: 03/14/2020 9:48:01 AM
Post# of 153915
“Hulk , I think we very lucky to have Leronlimab available during this time of COVID-19.”
Is leronlimab really available for COVID-19? I’d say no and given the FDA’s past history with CYDY and small biotechs, the peak of COVID-19 may come and go without any leronlimab out there.
The FDA wants a pre-IND meeting, which tells me they will require some changes to the protocol. How long will it take to get that meeting? How long will the changes take? When approved, how many hospitals in high COVID-19 concentrated areas have vials of leronlimab? Will the enough data return quickly enough for Leronlimab to get some type of approval for the treatment of COVID-19 this year?
My hope is that we can at least prove that leronlimab works to fight COVID-19 and that maybe leronlimab will be approved for treatment of the virus before next season or when another similar virus begins to spread in the future.
Is leronlimab really available for COVID-19? I’d say no and given the FDA’s past history with CYDY and small biotechs, the peak of COVID-19 may come and go without any leronlimab out there.
The FDA wants a pre-IND meeting, which tells me they will require some changes to the protocol. How long will it take to get that meeting? How long will the changes take? When approved, how many hospitals in high COVID-19 concentrated areas have vials of leronlimab? Will the enough data return quickly enough for Leronlimab to get some type of approval for the treatment of COVID-19 this year?
My hope is that we can at least prove that leronlimab works to fight COVID-19 and that maybe leronlimab will be approved for treatment of the virus before next season or when another similar virus begins to spread in the future.
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