>>>Ha! Whatever. Certainly, Novavax interaction with regulators has been adversarial.<<<
Owned NVAX and sold on the vax run up. you can see my posts there on IV in 2016 and before Shouldn't assume it's not a legitimate issue.
Once owned a company that sold ligaments and other parts from cadavers. FDA decided on cold storage at a certain temperature. CEO said not until the FDA could provide him with a study that showed cold storage made a difference.
FDA withdrew approval of company products.. Some CEOs are just so clueless..
If the FDA wants you to change a procedure or add a procedure and you think it's not necessary just do it.,
You'll never win a pissing contest with FDA.