Regarding the dosing issue, according to Dr. JL ..
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Posted On: 12/15/2021 5:48:39 PM
Regarding the dosing issue, according to Dr. JL ... the "FDA saw Covid as an acute viral illness and would only allow the same 2 week dose regimen".
It is possible that the FDA didn't understand the disease very well and thought that a therapeutic needed to fight off the viral load -- and it would have to do so in the first two weeks or it wouldn't happen. Clearly, almost all of the other therapeutics were attacking the viral phase of the illness.
It is also possible that someone in the FDA figured out a great way to sideline LL by limiting our dosing.
I am more inclined to believe the first option.
And that the DSMC that Amarex chose, and we rubber stamped, was ineffective at best. And very likely the member with strong GILD ties exercised their influence to ensure that we did not have the guidance that would have lead to a successful trial.
It is possible that the FDA didn't understand the disease very well and thought that a therapeutic needed to fight off the viral load -- and it would have to do so in the first two weeks or it wouldn't happen. Clearly, almost all of the other therapeutics were attacking the viral phase of the illness.
It is also possible that someone in the FDA figured out a great way to sideline LL by limiting our dosing.
I am more inclined to believe the first option.
And that the DSMC that Amarex chose, and we rubber stamped, was ineffective at best. And very likely the member with strong GILD ties exercised their influence to ensure that we did not have the guidance that would have lead to a successful trial.
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