Humanigen Inc (fka HGENQ)

[cowtown jay]

In terms of manufacturing agreements with our CMO's, the company said the following in their 10-Q.

"As of March 31, 2021, the Company estimates that its commitments remaining to be incurred during 2021 will amount to approximately $169 million. The agreements contain customary cancellation clauses."

see page 14

https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465921005311/h51021110q.htm

That's a legal filing signed by Durrant and Morris.

But I come back to what I consider an astounding statement in this regard, made in the press release yesterday, which I previously noted.

"In the second quarter of 2021 the company anticipates the amount of spending on lenzilumab production will be at least the same level as the first quarter of 2021. If an EUA or CMA for lenzilumab is not received by mid-2021, the company will seek to decrease or eliminate spending on the production of lenzilumab for commercial use."

Under Cash and Cash Equivalents

https://ir.humanigen.com/news/news-details/2021/Humanigen-Reports-First-Quarter-2021-Financial-Results/default.aspx

So, is the company basically saying to the FDA that:

a. we'll file the application for an EUA by the end of this month, and

b. then you've got 4 weeks to approve it, or else we're going to possibly eliminate production for commercial use?

I would find that hard to believe. Is this the company executives playing hardball with the regulators? I had said earlier, "The purse is so fat, I'm really glad that we have Durrant and Chappell to safeguard our potential."

But I haven't seen anything that "in your face" since the previous Administration. Certainly that can't be right...right? If it is right, maybe it's a reaction to being sidelined for so long during enrollment, or not yet being selected for the EU, when less effective drugs were. Or being perhaps penalized by having to reduce our Hazard Ratio from 1.90 to 1.54, because the Brazilian test sites ran out of oxygen, etc., for the trial patients. Why not just let the company enroll the number of Brazilian patients that were adversely impacted by this treatment failure, which had nothing at all to do with Humanigen?

I think the FDA's Office of the Inspector General (OIG for HHS) should be made aware of this.