PhrmaBro, thank you so much for sticking with me on this subject. I was getting about as uncomfortable with this subject, as I was with discussion about CYDY.
But to me, both subjects were critical to developing my understanding of Humanigen's circumstances. CYDY was a manifestation of our manipulation. I understood our manipulation more fully when comparing our share prices, and now, when comparing our market caps. The goal of the manipulators realized.
As far as this supply chain, I do not take the 1st and 2nd Quarter shocking statements about potentially ceasing production, and about our need for a timely EUA, lightly. This little exercise I did enabled me to develop just exactly the scenario that I think management is responding to. A gap in the time where we may be in between existing available inventory, and the arrival of new inventory, where the company's demand modeling program could simultaneously be indicating a sharp spike in demand. For the polished, experienced professional that Durrant is, to permit, and even take part in these shocking discussions, is a serious matter that I wanted to understand, at least to my own satisfaction. And I've done that.
You make an excellent, and corroborated observation regarding Emergent as an early lenz supplier.
"Humanigen and Emergent BioSolutions Announce Contract Development and Manufacturing Agreement for Phase 3 COVID-19 Therapeutic Candidate Lenzilumab
Jan. 25, 2021
Emergent will provide access to manufacturing capacity reserved for and provided by the U.S. government under Humanigen’s Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services."
If we were 4 - 6 weeks into a revenue stream, I think we could have contracted for additional "lines" of drug substance production. It's not a linear relationship with the remainder of the production process, since the mAbs can be frozen. Manufacturers could have then made available additional capacity they have agreed to do. Any depletion of finished product that may develop due to our lack of revenue to continue production could have been avoided, especially when demand could outstrip that of last year's demand.
What a shame, if we run out of desperately needed inventory, if it could have been avoided. So I understand some of the shine coming off of Durrant's polish.
Your discussion about 6 months reassures me, and I continue to very much appreciate your time.
"I'd expect much if not all of the EUA Drug Substance/Drug Product supply at launch to come from Catalent."
It appears that you are correct. “Catalent has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials,” commented Karen Flynn, President of Catalent Biologics and Chief Commercial Officer."
Also of note in that announcement is the following. "Humanigen’s investigational monoclonal antibody, lenzilumab, was developed using Catalent’s proprietary GPEx® cell line development technology." That's the platform capable of yielding 7 grams of product per liter.
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