Well this is definitely embarrassing for Zogenix! https://endpts.com/fda-snubs-zogenixs-anti-seizure-drug-not-happy-with-some-sloppy-inadequate-rd-work/
Zogenix medical and regulatory are a bunch of sloppy fools. This company just screwed a ton of dravet patients due to their incompetence. Can’t imagine what their sales leadership team is like. No apology on the call from the ceo just BS excuses.
The FDA are ball busters these days on new drug reviews. They essentially are delaying ALL approvals industry wide.
Although that may be true (but is not, name ones rejected vs approved), this was 100% on Zogenix. If it wasn’t we wouldn’t have Johnson Fistel LLC investigating us. Stop drinking the Kool-aid and blaming others (ie fda). This is a medical and regulatory blunder.
Play on words. Technically you can use rejected but delayed is the practical word to use here. Approval process will obviously be delayed a few months but product will still get approved.
No shit and that’s a good thing. But it should have been here sooner for these patients if it weren’t for our incompetence. Again, from the top down, we deny it was our fault. Jesus, such arrogance.
