Replies to post #28387 on Humanigen Inc (fka HGENQ)

[The Other Guy]

For the sake of catching the shorts off guard, I do hope the same. But realistically, we’ll have the application submitted in the next few days and then a quick approval. Based on all the discussion, it sounds as though the application is a necessary formality. Either way, I can wait it out. I am very confident in approval and moving forward.

[PhrmaBro]

Cowtown, I think we will hear about the EUA when it happens.

From an onlooker point of view, the approval process is incredibly slow. And the fact of the matter is the FDA is a bureaucracy - you are probably aware that getting approval of a new drug is not easy, and the the time between filing and approval is typically 6 months (priority review) to a year or more.

Even in the case of EUA, the FDA is well aware they are the gatekeepers here and an unwarranted EUA like hydroxychloroquine will be hung on them for a long time.

FDA will reviewing clinical data, manufacturing data, (they will likely audit the manufacturers), labeling, fact sheets, how and who should be administered the drug, etc.... all in high detail. They are not just calculating a p value.

The pre-meetings are to be sure all the necessary information is in the EUA. Even if HGEN was as well prepared as possible for the EUA on Mar 29, there was still a lot to process and prepare.

My expectation is the 1 month to file, 1 additional month for approval as seen for Lily's MaB.