How I wish I could be a fly on the wall as Cytodyn
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Posted On: 08/19/2020 10:09:23 PM
How I wish I could be a fly on the wall as Cytodyn talks to the FDA about their review of the data from the Phase 2 trial. This may not happen as I fantasize it because I believe someone here said that all or most communication between a company and the FDA must be in writing. Can someone illuminate how communication is carried on in such a way that everything is documented?
Anyway, at some point, there may be some oral communications and the part that would most intrigue me would go something like this -
FDA: OK, Cytodyn, your data from Phase 2 is compelling for a Breakthrough Therapy Designation and since Leronlimab seems capable of meeting an unmet need in this time of Pandemic, we are going to approve Leronlimab for the treatment of Covid-19 patients, mild to moderate. Our question now to you is - How much stuff do you have?
Cytodyn: Yeah, about that - we could use some help. Monoclonal antibodies don't grow on trees. They take time to culture and all the facilities that could produce Leronlimab are booked up and it also takes time to set the process up and ensure quality, yada, yada, yada. We haven't gotten squat for help in this regard so far, so how do we proceed, you know, from ground zero?
FDA: Oh, boy! We just approved a white hot potato as a solution to the biggest health crisis in the world!
That's kind of how I imagine it. My power of imagination kind of fails at that point. But I do kind of imagine it something like shit hitting a fan! I pity the messengers who have to carry the shocking news through the bureaucracies of the government and have to deal with the politicians. Wow, what a mess! Like having a tiger by the tail!
Can anyone weigh in on how they see things proceeding? I can see a great desire by some to just throw a huge security cloak over the whole thing in an effort to play for time because time is going to be the scarcist commodity of all upon approval in my mind.
Yeah we have a solution to the health and economic crisis on paper but it's going to take some time to translate it into reality!
Anyway, at some point, there may be some oral communications and the part that would most intrigue me would go something like this -
FDA: OK, Cytodyn, your data from Phase 2 is compelling for a Breakthrough Therapy Designation and since Leronlimab seems capable of meeting an unmet need in this time of Pandemic, we are going to approve Leronlimab for the treatment of Covid-19 patients, mild to moderate. Our question now to you is - How much stuff do you have?
Cytodyn: Yeah, about that - we could use some help. Monoclonal antibodies don't grow on trees. They take time to culture and all the facilities that could produce Leronlimab are booked up and it also takes time to set the process up and ensure quality, yada, yada, yada. We haven't gotten squat for help in this regard so far, so how do we proceed, you know, from ground zero?
FDA: Oh, boy! We just approved a white hot potato as a solution to the biggest health crisis in the world!
That's kind of how I imagine it. My power of imagination kind of fails at that point. But I do kind of imagine it something like shit hitting a fan! I pity the messengers who have to carry the shocking news through the bureaucracies of the government and have to deal with the politicians. Wow, what a mess! Like having a tiger by the tail!
Can anyone weigh in on how they see things proceeding? I can see a great desire by some to just throw a huge security cloak over the whole thing in an effort to play for time because time is going to be the scarcist commodity of all upon approval in my mind.
Yeah we have a solution to the health and economic crisis on paper but it's going to take some time to translate it into reality!
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