Humanigen Inc (HGENQ)

[cowtown jay]

"Texas Medicaid is a joint federal and state health insurance program for low-income families, older adults, and persons with disabilities. The federal government matches each state's Medicaid spending at a predetermined rate that varies by state."

https://www.hhs.texas.gov/providers/medicaid-supplemental-payment-directed-payment-programs#:~:text=Texas%20Medicaid%20is%20a%20joint,rate%20that%20varies%20by%20state.

Several of the ACTIV-5 clinical test hospitals are in Texas.

United States, Texas
Hendrick Health - Hendrick Medical Center
Abilene, Texas, United States, 79601
Baptist Hospitals of Southeast Texas Site
Beaumont, Texas, United States, 77701
Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants
Dallas, Texas, United States, 75246
Methodist Hospital - Houston
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio - Infectious Diseases
San Antonio, Texas, United States, 78229-3901

https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4

We know that patients in ordinal scales 5, 6, and 7 were eligible for trial enrollment in ACTIV-5, as shown by the UT San Antonio test site.

https://lsom.uthscsa.edu/infectious-diseases/clinical-trial/bet-activ-5/

This patient inclusion criteria matches that specified in the above referenced clinicaltrials.gov guideline.

"Inclusion Criteria:

Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) (ordinal score 5, 6, or 7)."

Now, to step away for a minute, let's assume that I was speaking to AG Paxton, and he asked me why the primary outcome measure was not to reflect those patients in ordinal scale 7.

"Primary Outcome Measures :
Occurrence of mechanical ventilation or death at any point through Day 29 in subjects with ordinal scores of 5 or 6 at baseline [ Time Frame: Day 1 through Day 29 ]
Subjects in ordinal scores 5 or 6 at baseline with a CRP<150 mg/L at baseline and age<85 years"

How would I answer? I couldn't. I don't know why patients in ordinal scale 7 were eligible for enrollment in ACTIV-5.

Management might. I don't think there is anything wrong with us questioning the trial design, and asking management to inform the AG about this issue.

And it is an issue under the purview of the AG, especially if state funds were used in a trial that was designed with criminal intent.