I have the same concerns also, my wife (who works
Post# of 153773
(Total Views: 722)
Posted On: 07/15/2020 11:26:54 AM
I have the same concerns also, my wife (who works in finance) said that this sounds like giving too much data is leading to additional questions instead of helping show the efficacy and safety. It is a rule to not provide more info than necessary in taxes, it just leads to more questions. I think the bouncing ball of dose size from day one in the hiv trials has been used in this regard. If cytodyn just presented the combo trial with 350mg and safety at 350, we might not be going through all of this.
I doubt the deciding folks at the fda for the covid are the same assigned to the hiv BLA process, I’m sure they compare notes but the motivations and process is very different. My strong hope is that the data from the m2m trial is made public ASAP so the pressure can be put on the fda to not delay anything. The media and BP that Kelley was talking about want the data now, that is completely separate from the fda actions. There very well are countries ready to go with leronlimab based on the data, not just on the fda approval.
I doubt the deciding folks at the fda for the covid are the same assigned to the hiv BLA process, I’m sure they compare notes but the motivations and process is very different. My strong hope is that the data from the m2m trial is made public ASAP so the pressure can be put on the fda to not delay anything. The media and BP that Kelley was talking about want the data now, that is completely separate from the fda actions. There very well are countries ready to go with leronlimab based on the data, not just on the fda approval.
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