FDA goes off the rails with eua for new mab (monoclonal antibody)

#1

the fda, theoretical watchdog agency supposedly working in the interests of all americans, has granted eli lilly an emergency use authorization for its new monoclonal antibody product, bamlanivimab. the authorized dosage, 700mg, failed to meet efficacy standards required of phase II trials. This is not much of a surprise since the maximum dose used in trials, 7,000mg (yes, 10 times larger than the dose approved) failed to meet efficacy standards as well showing no significant improvement over placebos at either dosage.

more information here–

commentary and discussion here–

overall, something seems very wrong here. if the new standard for eua is going to be “at least it does no harm even if it does no good” it would be well for them to say so explicitly.

good luck to us all.

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#2

So what’s holding up the authorization for my treatment?

826Ă—620 61.4 KB

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#3

grandma says “eat bubbalu, eat.”

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#4

If you charged $5k per dose, you might have something there!

I have no inside info or anything here, but with the way this admin has absolutely destroyed the academic rigor of the relevant regulatory agencies, I would not trust anything coming out of them until they are well and truly purged of the contamination.

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#5

Why would I cut the price when I can’t keep up with demand?

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#6

of course, one reason for the action may be things like what is described in this article–

if you have trouble with the paywall, this is the most pertinent part–

"Only 55 people attended the Aug. 7 reception at the Big Moose Inn in Millinocket. But one of those guests arrived with a coronavirus infection. Over the next 38 days, the virus spread to 176 other people. Seven of them died.

None of the victims who lost their lives had attended the party."

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