Great news!! From the FDA website concerning "
Post# of 155536
(Total Views: 1058)
Posted On: 12/24/2020 9:32:11 PM
Great news!!
From the FDA website concerning "Open Label Protocol/Extension"....
"These are usually uncontrolled studies, carried out to obtain additional safety data (Phase 3 studies). They are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained. These studies require prospective Institutional Review Board (IRB) review and informed consent." (bold is by me)
Pretty much sums it up...The FDA is basically giving us the nod that they expect leronlimab to gain approval once the data is collected and unblinded. IMO, there's no way the FDA would allow leronlimab to continue to be used unless they 1) knew it was safe and 2) knew it was working!
Can't wait for the coming weeks!
From the FDA website concerning "Open Label Protocol/Extension"....
"These are usually uncontrolled studies, carried out to obtain additional safety data (Phase 3 studies). They are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained. These studies require prospective Institutional Review Board (IRB) review and informed consent." (bold is by me)
Pretty much sums it up...The FDA is basically giving us the nod that they expect leronlimab to gain approval once the data is collected and unblinded. IMO, there's no way the FDA would allow leronlimab to continue to be used unless they 1) knew it was safe and 2) knew it was working!
Can't wait for the coming weeks!
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