In response to the comment below, we all need to r
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Posted On: 05/12/2022 12:46:47 PM
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???
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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