This is just my assumption. I could easily be wro
Post# of 154704
(Total Views: 663)
Posted On: 08/15/2020 3:06:07 AM
This is just my assumption. I could easily be wrong.
Whether or not the FDA grants CytoDyn an EUA, or grants a Phase 4 Confirmatory, or demands a Phase 3 -- I will be surprised if the government does not make an overture to buy the entire 2020 inventory or leronlimab.
This generally seems to be the government's MO, including buying all of the available inventory of Regeneron's cocktail therapy before the trials even began.
Even if the FDA demands a Phase 3, if there is a strong sense of potential efficacy, I don't think they will have a choice.
Furthermore, CytoDyn's M/M top-line submission for approval to the UK, EU, Mexico, and Israel creates not only the threat of a preemptive ex-US approval, it also creates the risk of a fully-depleted 2020 inventory.
If this assumption is correct, we will need to learn if CytoDyn and the government can arrive at a mutually agreeable price. I suspect they will. However CytoDyn's apparent resistance to applying for any government programs seems rooted in not wanting to be bound by any pricing or distribution constraints that are likely attached to those agreements.
Again, this is just my assumption. I could easily be wrong.
Whether or not the FDA grants CytoDyn an EUA, or grants a Phase 4 Confirmatory, or demands a Phase 3 -- I will be surprised if the government does not make an overture to buy the entire 2020 inventory or leronlimab.
This generally seems to be the government's MO, including buying all of the available inventory of Regeneron's cocktail therapy before the trials even began.
Even if the FDA demands a Phase 3, if there is a strong sense of potential efficacy, I don't think they will have a choice.
Furthermore, CytoDyn's M/M top-line submission for approval to the UK, EU, Mexico, and Israel creates not only the threat of a preemptive ex-US approval, it also creates the risk of a fully-depleted 2020 inventory.
If this assumption is correct, we will need to learn if CytoDyn and the government can arrive at a mutually agreeable price. I suspect they will. However CytoDyn's apparent resistance to applying for any government programs seems rooted in not wanting to be bound by any pricing or distribution constraints that are likely attached to those agreements.
Again, this is just my assumption. I could easily be wrong.
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