Respert: Great discussion with ohm and MLAB. As a
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Posted On: 11/23/2023 12:14:34 PM
Respert: Great discussion with ohm and MLAB. As a contrarian, my 2 cents is still riding on an emergency use approval conditioned on conducting a phase 4 trial pursuant to a FDA approved trial protocol.
If MLAB is correct that the FDA, for a variety of reasons, has taken pity on CYDY and is seeking to facilitate the availability of LL for HIV patients, then the quickest and easiest way to do that is for the FDA to determine that some sub population of HIV patients has an unmet medical need (probably based on pernicious side effects). With that finding and per FDA regulations, the door is then open for an emergency use approval based simply on a benefit/risk assessment of LL re the identified sub population. Under that process, the phase 4 trial is the final piece.
Call me crazy, but the EUA just seems like a far easier and timely way to right a wrong and throw a bone to HIV patients and advocates.
Happy Thanksgiving to all.
If MLAB is correct that the FDA, for a variety of reasons, has taken pity on CYDY and is seeking to facilitate the availability of LL for HIV patients, then the quickest and easiest way to do that is for the FDA to determine that some sub population of HIV patients has an unmet medical need (probably based on pernicious side effects). With that finding and per FDA regulations, the door is then open for an emergency use approval based simply on a benefit/risk assessment of LL re the identified sub population. Under that process, the phase 4 trial is the final piece.
Call me crazy, but the EUA just seems like a far easier and timely way to right a wrong and throw a bone to HIV patients and advocates.
Happy Thanksgiving to all.
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