(Total Views: 528)
Posted On: 02/01/2022 4:48:19 PM
Post# of 151689
Long-haulers would be a complex undertaking given the nuances and individual patient condition...But, if they could formulate a way to introduce it to the general medical community as a retardant on progression to serious...the SAE's are negligible...and the rewards are substantial...
These people are having a hard time fitting back into the workforce and life in general...NOT a doctor...talking through my hat.
If the FDA follows its own mantra...then safety has to be job one. "Where a delay would impose an unnecessary hardship on an applicant."...constitutes a priority.
The five stages in the FDA's acceptance of a prescription drug...
(a) discovery/concept..
(b) Pre-clinical research...
(c) Clinical research
(d) FDA review
(e) FDA post post-market Safety monitoring...
HIV patients have already proven the safety of the Molecule.
These people are having a hard time fitting back into the workforce and life in general...NOT a doctor...talking through my hat.
If the FDA follows its own mantra...then safety has to be job one. "Where a delay would impose an unnecessary hardship on an applicant."...constitutes a priority.
The five stages in the FDA's acceptance of a prescription drug...
(a) discovery/concept..
(b) Pre-clinical research...
(c) Clinical research
(d) FDA review
(e) FDA post post-market Safety monitoring...
HIV patients have already proven the safety of the Molecule.
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