Tuesday, October 05, 2021 9:10:13 PM
https://kvgo.com/guggenheim/humanigen-inc-oct-2021
There's a few things worth noting in this post. First is acknowledging that the company is trying to provide the FDA with all they need for an EUA. But they are bracing for the need to have the NIH trial serve as a confirmatory study. However, we are only about 65% enrolled. That comes to 260 total patients for a trial size of 400. So I'm afraid that could take awhile to complete enrollment, if necessary. But the FDA has not said that an additional trial is necessary.
But secondly, the company is focused on the CMA from the UK. That could provide the first couple of billions of dollars in revenue for us. If that leaves the DOD and the HHS shorthanded, too bad. Breakout some OWS funds, which we never received, and get a Defense Procurement Order signed, and help us provide the 1.5M treatments you have ordered from competing companies for their therapeutics.
And as I have been noting all along, the NIH has not changed their primary endpoint to SWOV. Dale acknowledged that the primary endpoint was going to be Time to ventilation or death. But, that will be measured against our target population of patients with <150 mg/L of CRP.
https://clinicaltrials.gov/ct2/history/NCT04583969?A=1&B=48&C=Side-by-Side#StudyPageTop
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