Shorts are trying to have damage control....
The FDA already knows the efficacy endpoints of the study data, this is not in dispute for the FDA. They want to know if panel sees a BENEFIT vs any risks from the device!!! PERIOD.
DOn't be fooled by senseless SHORTS trying to recover losses...
When will we know if it's fda approved. Will they ask for more time now that adcom has voted?
My question is which two voted that it had a benefit even though they apparently don't believe that it works??
they may believe it "works" but the questions was does the data support efficacy?