Humanigen Inc (HGENQ)

[cowtown jay]

Is this the type of safety and efficacy data that the FDA wanted to see for authorizing lenz for covid (besides our ACTIV-5 data which appears comparable to the data used to authorize Gohibic for late stage patients)?

"In the open label, nonrandomized PREACH-M trial, 72 patients with CMML were enrolled...

Among patients in the lenzilumab arm there was a 5.1-fold decrease in monocyte counts (P = .03) and 2.4-fold decrease in blast counts (P = .04) at 12 months of follow-up.

In addition there was a trend toward increased platelet counts over baseline at 12 months, a significant increase in blood hemoglobin concentration (P = .024), a significant reduction in spleen size (P = .03) and a trend toward lower levels of the inflammatory marker C-reactive protein...

Thomas told Medscape that the investigators have been "pleasantly surprised” at how well patients tolerated the monoclonal antibody.

"We haven't had any infusion reactions, we haven't had any pulmonary alveolar proteinosis, we haven't had any fevers from the infusion, from the antibody,” he said."

Each parameter (blood monocytes, bone marrow blast percentage, platelet count, blood hemoglobin concentration, and spleen size) has exhibited a durable return to normal or near normal values, with statistical significance. Two of the ten participants have been in the trial for 18 months, the longest of any participants, and exhibit lasting improvement. No participants have relapsed. One participant is now a candidate for stem cell transplantation, which may lead to a potential cure in that patient."

Additionally, there has been a notable increase in the number of Chinese nationals illegally crossing our southern border. A Chinese company was found to have opened an illegal biotech operation in California, which possessed several lethal viruses stored on site, and hundreds of mice bio-engineered to catch and carry covid. Does the FDA really want to see all of our lenz sold overseas?

In addition, nearly a "...dozen Russian and Chinese ships that sailed near Alaska's Aleutian Islands last week as part of a joint exercise -- leading the U.S. to deploy warships and aircraft to monitor the formation -- are now moving away from the region, according to two American officials."

https://abcnews.go.com/Politics/dozen-russian-chinese-ships-now-moving-alaska-officials/story?id=102074925

If the US government hasn't approached/ordered Humanigen to produce a stockpile of lenz for national defense, how much more provocation is it going to take to get them to admit that we have no Medical Countermeasures available to prevent or treat our population against a new wave of covid, especially if it is bio-engineered as a weapon?