I agree its possible that Nader's desire to mainta
Post# of 153815
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Posted On: 08/21/2020 11:13:39 PM
I agree its possible that Nader's desire to maintain good relations with US agencies may lead Nader to slow roll the UK covid approval process.
However, I think that is not the likely situation.
I believe a more likely situation is that Nader has elected to seek a UK approval for covid in order to pressure the FDA into approving leronlimab for covid.
The first fact suggesting it is Nader who is applying the pressure is that the UK Fast Track approval for covid cannot be rescinded. Once you send it in, the fuse is lit and the clock is ticking.
Second fact suggesting it is Nader who is applying the pressure is that the leronlimab UK combo HIV BLA was submitted on a 350 milligram dose. Combo HIV BLA in US is all about 700 milligrams.
Cytodyne was initially in favor of 700 milligrams, not only because it should work better but also because the FDA gave the bonus of no repeat combo trials at 700 milligrams. The FDA simply said for CYDY to do safety at 700 milligrams in the mono HIV trial.
This particular feature of CYDY's combo HIV BLA may be unprecedented in the history of the FDA. Has the FDA ever approved a drug at a dosage twice as high as what was trialed? I don't know. But that is what would happen in combo HIV leronlimab BLA. The human trials were conducted at 350 milligrams but the FDA may approve at 700 milligrams. Unprecede nted? I don't know.
But when the FDA issued a RTF instead of a PDUFA date for combo HIV, it apppears to me that Nader was no longer happy with the FDA's work on the combo HIV BLA.
So within days of recieving the combo HIV RTF, Nader decided to send a message to the FDA that he was unhappy, and that message was sent by filing the UK HIV combo BLA at 350 milligrams instead of 700 milligrams.
So, in my opinion, Nader is using the UK to apply pressure to the FDA.
Nader took his best shot.
Maybe the UK MHRA will bite on covid, but I doubt it.
The UK agency doesn't want to be used as a pawn by Nader and CYDY.
Unless of course Nader's gambit serves the UK agency in some other way for some other reasons that are not related to the efficacy of leronlimab.
If the UK agency sees some utility in Nader's gambit then they will go for it.
But what do I know? Probably nothing. Prerhaps I am totally wrong identifying as gamesmanship what is really just common sense.
Probably they filed the 350 milligram BLA with UK just to find the quickest path to commercial sales. With the FDA RTF at 700 milligrams, seems an obvious conclusion that 350 approval would be quicker in UK?
And filing for covid EUA in UK, or anywhere else, is simply a natural step given that covid EUA was filed with FDA.
However, I think that is not the likely situation.
I believe a more likely situation is that Nader has elected to seek a UK approval for covid in order to pressure the FDA into approving leronlimab for covid.
The first fact suggesting it is Nader who is applying the pressure is that the UK Fast Track approval for covid cannot be rescinded. Once you send it in, the fuse is lit and the clock is ticking.
Second fact suggesting it is Nader who is applying the pressure is that the leronlimab UK combo HIV BLA was submitted on a 350 milligram dose. Combo HIV BLA in US is all about 700 milligrams.
Cytodyne was initially in favor of 700 milligrams, not only because it should work better but also because the FDA gave the bonus of no repeat combo trials at 700 milligrams. The FDA simply said for CYDY to do safety at 700 milligrams in the mono HIV trial.
This particular feature of CYDY's combo HIV BLA may be unprecedented in the history of the FDA. Has the FDA ever approved a drug at a dosage twice as high as what was trialed? I don't know. But that is what would happen in combo HIV leronlimab BLA. The human trials were conducted at 350 milligrams but the FDA may approve at 700 milligrams. Unprecede nted? I don't know.
But when the FDA issued a RTF instead of a PDUFA date for combo HIV, it apppears to me that Nader was no longer happy with the FDA's work on the combo HIV BLA.
So within days of recieving the combo HIV RTF, Nader decided to send a message to the FDA that he was unhappy, and that message was sent by filing the UK HIV combo BLA at 350 milligrams instead of 700 milligrams.
So, in my opinion, Nader is using the UK to apply pressure to the FDA.
Nader took his best shot.
Maybe the UK MHRA will bite on covid, but I doubt it.
The UK agency doesn't want to be used as a pawn by Nader and CYDY.
Unless of course Nader's gambit serves the UK agency in some other way for some other reasons that are not related to the efficacy of leronlimab.
If the UK agency sees some utility in Nader's gambit then they will go for it.
But what do I know? Probably nothing. Prerhaps I am totally wrong identifying as gamesmanship what is really just common sense.
Probably they filed the 350 milligram BLA with UK just to find the quickest path to commercial sales. With the FDA RTF at 700 milligrams, seems an obvious conclusion that 350 approval would be quicker in UK?
And filing for covid EUA in UK, or anywhere else, is simply a natural step given that covid EUA was filed with FDA.
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