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Posted On: 12/10/2020 10:12:31 PM
Post# of 148908
The point of my post#67690 was to point out the danger I saw to all of the indications that Leronlimab can treat by a quick grab for the gold of the Philippines.
This is what I heard - we have 1.5 million vials in stock and if the Philippines FDA clears Leronlimab for EUA there and they give us $2.5 billion, they get it all.
Isn't that what was said?
In the replies to my message, people were saying, like FBCoach18, "I'm obviously not privy to any discussions behind the scene at CYDY. But with my heart of hearts, and through DD, I'm sure they will do the right thing." (FB, thank you for your reply!)
Then why was it said in the CC? At this point in time, things said like this are dangerous. Didn't Trump just sign an executive order along the lines of no export of vital Covid-19 drugs? Pourhassen was even asked if he thought that executive order could pertain to Cytodyn. He said he didn't think so, meaning he doesn't know for sure!
People said if we need more Leronlimab, surely the government will "step in," as Ohm20 said. Cytodyn already checked this out and they didn't like what they heard. This is what they heard -
https://www.npr.org/sections/health-shots/202...rotections
I quote, "Normally, contracts for federal funding toward the development of a drug or vaccine include Bayh-Dole rights, allowing the government to "march in" and take over a drug or vaccine if the manufacturer that received federal funding can't or won't make its product on reasonable terms."
Cytodyn didn't like the sound of that no doubt, being a one-trick pony that intends to treat dozens of indications, not just Covid-19!
These "march-in" rights, that are found in normal time in agreements that take taxpayer money, are doubly off-putting in pandemic times!
Have people forgotten the "Defense Authorization Act" that already had manufacturing plants pumping out ventilators last spring?
And then there's CDER. CDER's job is to make a company who wants to market a drug in the US with FDA approval to jump through a lot of hoops. They especially want to know about manufacturing. I'm not going to spell out any of the details here when anyone can Google CDER and see what is required for approval.
My point was it doesn't help your cause to piss the FDA or CDER off. You don't want to piss anyone off. If you do, perhaps you will end up fighting the government that could be helping you or they could look the other way as BP eats you lunch, as I said before.
Anyway, I heard what I heard on the CC and I thought it was dangerous. Things are different in the big leagues and things are more political and enemies will try to hurt us. We need goodwill in high places. I hope FBCoach18's sentiments are warranted.
Read the article!
This is what I heard - we have 1.5 million vials in stock and if the Philippines FDA clears Leronlimab for EUA there and they give us $2.5 billion, they get it all.
Isn't that what was said?
In the replies to my message, people were saying, like FBCoach18, "I'm obviously not privy to any discussions behind the scene at CYDY. But with my heart of hearts, and through DD, I'm sure they will do the right thing." (FB, thank you for your reply!)
Then why was it said in the CC? At this point in time, things said like this are dangerous. Didn't Trump just sign an executive order along the lines of no export of vital Covid-19 drugs? Pourhassen was even asked if he thought that executive order could pertain to Cytodyn. He said he didn't think so, meaning he doesn't know for sure!
People said if we need more Leronlimab, surely the government will "step in," as Ohm20 said. Cytodyn already checked this out and they didn't like what they heard. This is what they heard -
https://www.npr.org/sections/health-shots/202...rotections
I quote, "Normally, contracts for federal funding toward the development of a drug or vaccine include Bayh-Dole rights, allowing the government to "march in" and take over a drug or vaccine if the manufacturer that received federal funding can't or won't make its product on reasonable terms."
Cytodyn didn't like the sound of that no doubt, being a one-trick pony that intends to treat dozens of indications, not just Covid-19!
These "march-in" rights, that are found in normal time in agreements that take taxpayer money, are doubly off-putting in pandemic times!
Have people forgotten the "Defense Authorization Act" that already had manufacturing plants pumping out ventilators last spring?
And then there's CDER. CDER's job is to make a company who wants to market a drug in the US with FDA approval to jump through a lot of hoops. They especially want to know about manufacturing. I'm not going to spell out any of the details here when anyone can Google CDER and see what is required for approval.
My point was it doesn't help your cause to piss the FDA or CDER off. You don't want to piss anyone off. If you do, perhaps you will end up fighting the government that could be helping you or they could look the other way as BP eats you lunch, as I said before.
Anyway, I heard what I heard on the CC and I thought it was dangerous. Things are different in the big leagues and things are more political and enemies will try to hurt us. We need goodwill in high places. I hope FBCoach18's sentiments are warranted.
Read the article!
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