Thanks @LearningEachDay and @stockrock, you guys are bringing some sanity back to these threads - hey, the sky is not falling after all!
What frustrate me more than anything is the sense of urgency is lost to the FDA.
Sure, the urgency was there for Vaccines - and that get applied to lot more people - where is the LT study of side-effects etc... that's ok, on balance it's better to have the Vaccine to protect the population
But, for a treatment that shows promises, the FDA is willing to take it nice and slow, to follow due process - hello FDA!!!
We are still in the midst of a pandemic - there are simply too many people dying
... and where is NIH - they seen enough data at Mt Sinai and acted; but, now we have much more data and they are not re-acting???
Something is very wrong here in the land of the FDA - no wonder the Acting FDA Commissioner Woodcock is pushing for an external review!
I'm looking forward to EUA - but, c'mon move it along FDA!!!
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