Humanigen Inc (HGENQ)

[Corundum]

The CYDY EUA attempt will fail due to a variety of factors (bad study, bad statistics, etc) But there may be an underlying effect that should be investigated. CYDY has sliced and diced the data to show a 14-day mortality benefit that is very large, on a patient population that is very small. They are hoping that the FDA will ignore the fact that 28-day mortality benefit is only modest. They go on to admit that their dosing may be inadequate for the full 28 day study (dosing was at day 0 and day 7) and that they may need additional doses (such as Day 14 and Day 21) The FDA will, of course, say fine, give us a study that shows your revised dosing and has enough patients to meet statistical significance. Maybe eventually CYDY will sell their drug as "we can keep you alive on vent for as long as you want as long as you keep on dosing and paying for it". The interesting thing is that if you look very carefully at the Thwaite chart (almost impossible to actually do) there appeared to be a signal that CC5L is in fact highly elevated in critical patients. Lenzilumab possibly helps with that, too. The government is studying our drug Lenzilumab in criticals, although it is not a Phase 3 study. However, I believe CYDY's drug will eventually have to beat any results that Lenz is able to achieve. If they can help with critical patients, more power to them. But they have to prove it, which they have not done. Add to that their terrible management, lack of capital, and flaky study designs and flaky study results, and you have a recipe for disaster.