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Re: jessellivermore post# 184615

Saturday, 03/30/2019 1:09:42 PM

Saturday, March 30, 2019 1:09:42 PM

Post# of 426572

I'm still perplexed about how they can say SOC for an indication that lacks the FDA label...




It certainly runs against precedent, but the lost opportunity cost is formidable.

Take the low dose aspirin riff, which came and went. The only losers are those who got no benefit at nominal cost and the manufacturers who are set up for a gazillion tons of baby aspirin, all post outcome study.

V is post outcome study. And it was gonna happen. The ADA moved at (at the moment) no cost. The pressure on the street builds in terms of preventable events. Maybe, maybe not at all at the Administration headquarters. Thalidomide, Celebrex, et al. It's not long in terms of a priority review and it can be conditional and disclaimered out the wazoo about being outside of normal, accepted and still in place protocols and procedures.
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