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Posted On: 10/20/2020 12:10:15 PM
Post# of 145247
I appreciate your frustration as it is absurd to think that we have a drug with no SAEs warming the bench when it has already shown that it can save lives. But, I will point out that I don't think we know anything other than the DSMC's recommendation at this point, which is, let's check back sooner than later because this leronlimab is showing a lot of promise.
You'll note the following in the PR
This is what I hope to find out more about this afternoon. This is where the FDA can do the right thing or let more patients suffer IMO. I am still optimistic that good will come of this and am hopeful CytoDyn received enough information back that they can pursue these other regulatory pathways/partnerships (everyone was waiting on the data, do we have what we need data-wise to satisfy those waiting?)
I look at the DSMC recommendation as the canary in the coal mine. And he's still singing a happy tune. Let's hope we get some clarity this afternoon about these different potential pathways forward. That will help address the questions you are asking I believe.
GLTU!
You'll note the following in the PR
Quote:
Concurrently, we are seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.
This is what I hope to find out more about this afternoon. This is where the FDA can do the right thing or let more patients suffer IMO. I am still optimistic that good will come of this and am hopeful CytoDyn received enough information back that they can pursue these other regulatory pathways/partnerships (everyone was waiting on the data, do we have what we need data-wise to satisfy those waiting?)
I look at the DSMC recommendation as the canary in the coal mine. And he's still singing a happy tune. Let's hope we get some clarity this afternoon about these different potential pathways forward. That will help address the questions you are asking I believe.
GLTU!
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