The approvals game is not one we can win. If we le
Post# of 155138
(Total Views: 593)
Posted On: 12/07/2022 2:53:13 PM
The approvals game is not one we can win. If we learned anything from the Covid Pandemic and remdesivir, it surely would be that if you have a better drug, nobody cares. The road blocks that BP sets up are strong.
Take our HIV hold, that should be a clue. Gilead received a hold for real safety issues at the same time as CytoDyn. Theirs was lifted in 3 months; ours, for no safety issues over 8 years, is still there. And what happens when we submit data for the last two issues to the FDA, I bet slow walk. Then we do the trial for which there are all kinds of issues, then there issues with the product, the manufacturing, the delivery system, etc....one issue after another.
We need a partnership with BP, that is the game, that is the rules.
Take our HIV hold, that should be a clue. Gilead received a hold for real safety issues at the same time as CytoDyn. Theirs was lifted in 3 months; ours, for no safety issues over 8 years, is still there. And what happens when we submit data for the last two issues to the FDA, I bet slow walk. Then we do the trial for which there are all kinds of issues, then there issues with the product, the manufacturing, the delivery system, etc....one issue after another.
We need a partnership with BP, that is the game, that is the rules.
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