Humanigen Inc (HGENQ)

[portage1066]

I've reviewed FDA documents and can not find anything that mentions decline vs denial as separate classifications. Decline is the the word that is used. If you have something that discusses denial vs decline, it would be helpful if you posted it.

Here's what I'm basing my thoughts on https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities

FDA may decline to review or issue an EUA based on any number of factors. For example, the candidate product may fail to meet the necessary criteria identified in section 564 and discussed in section III.B.1 of this guidance, or it may fail to meet any one of the factors given the circumstances of the emergency or threat of emergency (see section III.D.4.a of this guidance for a discussion of factors FDA will consider in reviewing requests for prioritization of EUA requests). Under such circumstances, the relevant product Center will notify the sponsor that the EUA review cannot be prioritized or FDA declines to issue an EUA for the candidate product.