Humanigen Inc (fka HGENQ)

[cowtown jay]

STOP, dlog! Here's what the FDA tells us what a Decline determination means to them. It means that they are not going to review and process the EUA application. Period.

see the 1st bullet point
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-25-2021

If the material in the EUA application hasn't even been reviewed, then no conclusion can be derived about the likelihood of either a Denial nor an Approval, had the material been reviewed. The SEC and the DOJ therefore have no basis to conclude that the FDA Declined our Approval, when it is just as possible to conclude that the FDA Declined our Denial, since we are conflating determinations.

I want to stop right here for now, (but there is more to be said) because what I outlined means that there is no basis for the charges filed by the SEC and the DOJ, based on the FDA's decision to Decline the review and processing of our EUA application.