In some cases, the FDA will tell the biomed company that submitted an app that it finds what info it provided as insufficient to grant an approval for an NDA, so back to the drawing, as that trite old saying goes. If the approval isn't granted, one would think all this hysteria was engineered by insiders with the help of persons close to the insiders.
I think, last time I checked, it's called a pump and dump.
Not that unusual when it comes to the 458 biomed stocks on the Barchart sector I sometimes check.
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