Humanigen Inc (HGENQ)

[The Other Guy]

Good perspective on the situation. As Cameron indicated in the company update, it is unknown why the EUA was declined. The FDA has not provided sufficient feedback or clarification. Was it the trial size? Was it effectiveness vs. safety? Was it cost of the treatment? Something else deeper in the data?

The company received a vague, template response. It’s easy to make negative arguments (as many trolls do) when information is vague.

My hope is the Type-B meeting opens up the dialogue and gets the company the specific information needed to push an approval. Big Pharmas have an advantage over small companies because they have contacts inside the FDA (former employees or previous contacts from other meetings) they can rely on. Seems to be a major disadvantage for small companies - despite how well the tech is.

All this gives the appearance of political influence that BP has on the FDA. Right or wrong, it is happening. But, I believe the FDA will do the right thing eventually. The question becomes how much damage will be done to the business. Supply chain disruption has already taken place. Available doses of lenzilumab will be less because of production halt. We’re already incurring an increase in available shares. How much more?