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Posted On: 12/10/2020 6:10:08 PM
Post# of 145876
The most shocking part of the CC was the discussion of who would get the 1.5 million vials of Leronlimab if someone approved an EUA - Pourhassen said it would be first come, first served! Anyone with $2.5 billion could walk away with it all!
That would be a very bad idea! If someone other than the US gets all of the available Leronlimab, I don't see Cytodyn and Leronlimab getting past CDER (Center for Drug Evaluation and Research).
As I have said over and over again, if Cytodyn can not supply Leronlimab in significant quantities in the US, the FDA will not approve Leronlimab! That would be a disaster! It is not just a matter of passing the drug trials!
The available Leronlimab must have significant availability in the US or we will be cut off, also, from any help from the government to make more Leronlimab. We need funding and facilities and the ability to "jump the line" if need be. We are HIGH PRIORITY!
It was made abundantly clear in this CC that the need for Leronlimab could be in the billions of vials in the long run and around the world. That is not possible by any stretch of the imagination in the short run.
All attention must be paid to keeping Cytodyn in everyones' good graces or we will get, in effect, retaliation from aggrieved parties (countries). Further we need protection from BP! If we piss people off, BP will be happy to eat our lunch!
The politics of this could get very scary. We need the government as an ally, not an adversary! Blundering into this dimension of this pandemic could be fatal! I would advise extreme caution as the real power of Leronlimab is demonstrated. No stupid shoot-from-the hip stuff or attempts to "force anyones' hands!"
Cytodyn must do its best to please everyone! Create no enemies!
That would be a very bad idea! If someone other than the US gets all of the available Leronlimab, I don't see Cytodyn and Leronlimab getting past CDER (Center for Drug Evaluation and Research).
As I have said over and over again, if Cytodyn can not supply Leronlimab in significant quantities in the US, the FDA will not approve Leronlimab! That would be a disaster! It is not just a matter of passing the drug trials!
The available Leronlimab must have significant availability in the US or we will be cut off, also, from any help from the government to make more Leronlimab. We need funding and facilities and the ability to "jump the line" if need be. We are HIGH PRIORITY!
It was made abundantly clear in this CC that the need for Leronlimab could be in the billions of vials in the long run and around the world. That is not possible by any stretch of the imagination in the short run.
All attention must be paid to keeping Cytodyn in everyones' good graces or we will get, in effect, retaliation from aggrieved parties (countries). Further we need protection from BP! If we piss people off, BP will be happy to eat our lunch!
The politics of this could get very scary. We need the government as an ally, not an adversary! Blundering into this dimension of this pandemic could be fatal! I would advise extreme caution as the real power of Leronlimab is demonstrated. No stupid shoot-from-the hip stuff or attempts to "force anyones' hands!"
Cytodyn must do its best to please everyone! Create no enemies!
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