In the past I have thought maybe we should go against the FDA try to push them a little, but not at this point not right now. If our results are hitting both primary and secondary endpoints and still no approval then cry foul but not yet. so B52T38- I totally agree with you about playing by the rules .
The company owns the data.....the FDA historically NEVER NEVER tells a company not to do a press release.....they dont give a shit about investors and PRs. They follow a strict process for bringing drugs to market. Did tbey tell any of the vaccine companies to not release their topline results before EUA....hell no.