Humanigen Inc (fka HGENQ)

[cowtown jay]

The reporter in your referenced article notes, "Of the 37 drugs approved by the FDA last year, 24 (about 65%) were approved based on just one study, according to a paper published in JAMA Network Open."

https://nypost.com/2023/08/24/fda-fast-tracking-approval-of-new-drugs-fewer-trials-less-info/

The reporter laments what he described as, "...a significant departure from the more rigorous vetting process the agency (FDA) was previously known for."

I am really conflicted on this issue. The first reported case of covid in the United States was in March 2020.

"Although we found that SARS-CoV-2 likely began spreading in New Orleans mid-February, 2020, the first official COVID-19 case was not reported until March 9th."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7872376/#:~:text=Although%20we%20found%20that%20SARS,reported%20until%20March%209th.

And it was just one year later when Humanigen reported the topline data (TLD) from the LIVE-AIR trial.

“Mayo Clinic is pleased to have been part of the investigation of lenzilumab from the earliest days of the development program in COVID-19 and are excited by these data,” said Andrew Badley, MD, Professor of Infectious Diseases, and Professor and Chair of the Department of Molecular Medicine at Mayo Clinic. “If lenzilumab is authorized for emergency use by FDA, and based on our clinical trial experience to date, it may then be considered a part of our treatment armamentarium for newly hospitalized patients with COVID-19.”

https://www.businesswire.com/news/home/20210329005301/en/

To this day, I agree with Dr. Badley. Lenz should be the standard of care in the treatment of covid, and I hope that it will be, once our EUA is authorized, which I hope will be soon. I wished my wife's doctors would have agreed to her getting lenz as a compassionate use treatment before TLD was released.

On the other hand, I am very unsettled by the lack of long term treatment data regarding mRNA vaccines, especially when they are approved for infants that are 6 months old, and we are seeing altered immune systems in patients suffering with Long Covid.

https://www.cdc.gov/vaccines/covid-19/downloads/covid-19-immunization-schedule-ages-6months-older.pdf

How do we best safeguard our very young, and prevent the alteration of their immune response systems? If it is really necessary to vaccinate these infants, would the lenz/vaccine/anti-viral cocktail be a better alternative? The Novavax vaccine is approved for patients 12 years and older.

https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-formulated-better-protect-against-currently

If there really is a need to vaccinate infants, I would at least be more reassured if lenz was administered to help protect their innate immune systems. This could go from being a rhetorical discussion, to one that is very practical, once we have our EUA, and the medical community looks to expand the benefit offered by lenz.