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  4. CytoDyn Inc (CYDY) Message Board

In response to the comment below, we all need to r

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Post# of 155128
(Total Views: 565)
Posted On: 05/12/2022 12:46:47 PM
Posted By: sunclouds
Re: USS JOHNSTON #123099
In response to the comment below, we all need to realize that the no SAE comment in what we have been verbally told.
What counts in pharma is what is written down - hence the saying “If it isn’t documented, it didn’t happen”

Leronlimab is on clinical hold because amount other things, the regulatory agency is waiting for consolidated safety data to be submitted

The company needs to submit this in appropriate fashion to the FDA

The sooner the better

IMO


—————————————————————
would it not make sense to grant an EUA for a drug with no SAE's for 7 years on the most immunocompromised of all (AIDS patients), a drug that showed it helped mitigate 18 of 24 longhaulers symptoms?

Is this not a reasonable expectation of a public health agency?

Can the FDA/CDC/NIH get ANYTHING right???


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