Humanigen Inc (HGENQ)

[cowtown jay]

Scope.

After giving your questions much thought, and deciding how best to respond, I think "scope" best describes what is most beneficial in understanding where we are right now.

I have four Covid-related therapeutic stocks. CYDY, RLFTF, and IPIX all account for 11% each of my holdings, with HGEN accounting for the remaining 66% of my account. For some time, I was like many of the shareholders here who thought HGEN was the only stock worth investing in. But the other stocks I invested in have done amazing jobs in racing to FDA approval, along with HGEN. To me, the race is too close to call.

Where we will distance ourselves from the competition will come after product validation. I think that is the finish line for our competitors. But for us, it's the starting line for getting our product into the hospitals. We have done a lot of groundwork already that our competitors lack resources in developing.

Look at the business plan, what HGEN refers to as the Lenzilumab Partnership Framework. I talked about it in a previous post.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161074385

I credit the DOD CRADA with assisting the company in developing this business plan. As the company said, "The CRADA complements Humanigen’s development efforts, providing access to a full-scale,
integrated team of manufacturing and regulatory subject matter experts and statistical support
in anticipation of applying for EUA and subsequently a Biologics License Application (BLA)
for lenzilumab as a potential treatment for COVID-19. The CRADA also provides that federal
experts will work hand-in-hand with the company on U.S. Food and Drug Administration
(FDA) communications, meetings and regulatory filings. The CRADA aims to support the
ongoing lenzilumab Phase 3 clinical trials, focusing on efficiently generating EUA and BLA
submissions. In addition to providing access under EUA, the CRADA allows for lenzliumab to
possibly receive the benefits provided by Public Law 115-92."

https://s27.q4cdn.com/938944131/files/doc_news/archive/04aeb1ee-cb62-474a-b1c6-ea29e3b7662e.pdf

Now we have BARDA signed onto this agreement. As you noted, this will help gain access to manufacturing capacity. Specifically, this will help with fill finish production. "The amended CRADA, now co-signed by BARDA, provides Humanigen with access to manufacturing capacity reserved by BARDA for fill-finish product to accelerate the drug product manufacturing of lenzilumab."

https://ir.humanigen.com/news/news-details/2021/Humanigen-Announces-the-Addition-of-BARDA-and-Expansion-of-CRADA-with-the-U.S.-Government-to-Develop-Lenzilumab-for-COVID-19/default.aspx

I think this will lead to OWS funding, also, since you mentioned a more direct infusion of governmental funding.

Bottom line is that our competitors' management teams are largely focused on their product validations, and hoping to secure funding to accomplish all the things that we see the Humanigen team has already developed with their government partners.

I think it is very telling that our largest shareholder, Dale Chappell, who, like Durrant, is an MD with an MBA, recently resigned as our Chief Science Officer to resume his seat on the Board. I don't think there is any way in hell he would have done that if there was any chance of failing to get FDA approval.