CapnAmerica, We are all frustrated. Your concer
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Posted On: 10/20/2020 3:34:00 PM
Re: CaptnAmerca #62323
CapnAmerica,
We are all frustrated. Your concern for saving lives is appropriate and laudable. The anti-short position. EINDS require individual application by treating physician for each patient and remove the incentive to enroll in blinded, randomly assigned trials.
Delivery of leronlimab to thousands of patients requires EAU or approval. Neither of those will be granted on the anecdotal (weak) evidence from EINDs.
Dr. Seethamraju thankfully pushed for EIND to get the ball rolling, but that was truly just the staring point. Very similar to physicians repurposing existing medications (Il-6 blockers, steroids, invermectin, HCQ, etc). All the initial enthusiasm has to be followed by controlled studies, otherwise physicians are hampered by uncertainty and will never know what is PROVEN to work.
Treatment for many conditions has continued for years without clear answers (chronic/post-Lyme, chronic fatigue syndrome/myalgic encephalomyelitis, etc).
The delay to leronlimab approval is awful. The only acceptable equivalent to your suggestion of concurrent EIND and trials, would be EUA and Phase 4. Time will tell.
We are all frustrated. Your concern for saving lives is appropriate and laudable. The anti-short position. EINDS require individual application by treating physician for each patient and remove the incentive to enroll in blinded, randomly assigned trials.
Delivery of leronlimab to thousands of patients requires EAU or approval. Neither of those will be granted on the anecdotal (weak) evidence from EINDs.
Dr. Seethamraju thankfully pushed for EIND to get the ball rolling, but that was truly just the staring point. Very similar to physicians repurposing existing medications (Il-6 blockers, steroids, invermectin, HCQ, etc). All the initial enthusiasm has to be followed by controlled studies, otherwise physicians are hampered by uncertainty and will never know what is PROVEN to work.
Treatment for many conditions has continued for years without clear answers (chronic/post-Lyme, chronic fatigue syndrome/myalgic encephalomyelitis, etc).
The delay to leronlimab approval is awful. The only acceptable equivalent to your suggestion of concurrent EIND and trials, would be EUA and Phase 4. Time will tell.
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