Humanigen Inc (HGENQ)

[DonDonDonDon]

What if NIH is thinking the same thing as FDA?

I've always felt that the FDA and NIH are working completely in concert. That is why I felt that the expansion and change in patient population in the ACTIV-5 was a signal that the EUA wasn't coming at that time. Enrolling the ACTIV-5 would have been impossible if the EUA was granted because a doctor can't give a patient a placebo when the drug is available on the market. The expansion and patient pop change came at the exact time that the EUA was expected. So it seemed to me that they decided that they wanted more data before granting the EUA. At the same time, I felt that the ACTIV-5 trial expansion was confirmation that the EUA would eventually come. The government doesn't hesitate terminating a trial when they don't believe it is working.

Many who wanted to believe that the EUA "could come any day" pushed the idea that the FDA and NIH are separate entities with separate and at times opposing agendas. I never believed that made sense. The FDA and NIH work very closely together. They are made up of scientists who are smart and realize working together makes more sense than working against each other.