Aug. 18 at 3:52 PM
$VNDA Has any bio, even the big boys, ever challenged the FDA in court with regard to its authority to not approve a drug for any reason? From what I can tell, the is a first.
VNDA went to court to basically say the FDA had no authority to deny its drug approval because it violated its own protocols offering VNDA the chance for a hearing. I wonder how many other bios have had been denied hearings over the years.....my guess is many times it has happened. If the FDA didn't want to fool with justifying itself, I guess it just used its power to blow you off. Well, VNDA, by winning its case, opened the door for many other companies to have their drugs more carefully reviewed in the future is my bet.
VNDA's victory becomes a legal precedent under common law. I suppose if the FDA wanted to go to the Supreme Court on appeal, it could....but I don't think it will want to embarrass itself further. JMO.
I think this is a big deal for VNDA and its shareholders. IMO
