Welcome to Ihub, and to the room, jjson.
I said I received a phone call from Humanigen, so obviously that's all I wanted to say about that. I appreciated the phone call. But what I really want is a reply to my email, providing a copy of the FDA's Decline letter.
So I wrote a second email to the company, and said just that.
I haven't heard back. Perhaps I won't. I won't be following up anymore than that, because no further reply would mean they don't want to provide the FDA letter. And I can understand that.
You know what I said about the 200-250 patients in the trial, and you know Don provided what Scrip said about 300 patients. So you likely know that I told Don that I don't dispute Scrip's reporting. My caller may have been shooting from the hip, and the same may apply to Scrip's source, if the sources were different. The trial population is not static. They're enrolling. The most valuable takeaway is Don's DD about the 100 patient interim reviews, which could happen quickly as 300 patients are enrolled, and the DSMB is evidently getting real-time data on the patients.
You know, when the NIH Covid Treatment Guidelines were published, I was concerned that they cited our primary endpoint of SWOV as a Key Limitation of our trial design. I pointed out that the company was using the primary endpoint that the FDA was guiding to. The NIH wanted to use a mortality endpoint. A perfect example illustrating that the NIH and the FDA don't always agree.
I also am not convinced that the FDA and the NIH have our accelerated advance prioritized.
The NIH found insufficient evidence to Recommend the use of lenz as a GM-CSF inhibitor.
Just as the FDA closed their eyes to the benefit clinically determined by the use of lenz, claiming that they couldn't say that benefit outweighed the risk of this very safe drug.
After the NIH announcement, we didn't immediately hear from Durrant. He was busy take care of that problem.
Now, with the FDA decision, I expect he is taking care of that problem, also. Getting them data as quickly as possible, and perhaps getting assistance in making sure the FDA weighs the benefit vs risk appropriately.
Data has been going to the UK, with the rolling reviews. NICE wants the product. I hope that comes together this month, when the submission is completed. I was hoping we'd get a decision from the first Module Assessment Summary, since I interpreted a reference to Labor Day as a possible signal that could happen. But a 'Decline' decision could have caused a delay in the UK, for some of their verification purposes.
So nothing tells me that management is assuming only a little chance to get UK approval. More important than making inventory we can't sell is safeguarding our ability to maintain CMC compliance. That takes money.
