Humanigen Inc (HGENQ)

[cowtown jay]

The problem is not likely with the low level regulators who have their boots on the ground and are engaged with company staff through constant communication and site inspections. I was engaged with one such site inspector myself, when my staff couldn't provide satisfactory information regarding a process he had observed. He was fully aware of the protocol, and had the competency to accurately determine our compliance.

In the same way, I think our management was sure that we were meeting FDA requirements up until the time we submitted our EUA application. The Lancet and Thorax peer reviews validated the safety and efficacy of lenzilumab. So there was no justifiable reason to deny our EUA application. The FDA knew that. That's why they did not deny the application.

I believe it was just before, or during, the 104 days the FDA sat on our EUA application, that they exercised their discretionary authority to grant themselves a new power, the power to Decline to make a decision. That's what they then did to us. They Declined to make a decision on our EUA, claiming to want additional safety and efficacy data. That decision likely wasn't made by the FDA staff who did the grunt work with management to prepare for a successful submission. It was an arbitrary decision that effectively kept us out of the market, without having to justify their "non-decision."

Now, as we saw in the 'Live Science' article I referenced previously, the medical community is searching for a way to manage inflammation.

https://www.yahoo.com/lifestyle/dont-inflammation-then-youll-die-120009520.html

Lenzilumab has the Method of Action they are searching for. It is locked away from the medical community because of the FDA's abuse of their discretionary authority, using a newly imposed, self-granted power, to Decline to make a regulatory decision on our product.