Replies to post #32910 on Humanigen Inc (HGENQ)

[dloggold]

It’s kind of funny reading your posts,
When the application was announced, Durrant stated clearly the data supported EUA.
I think he and his team know a little more than you about what they are talking about.
You come across as a know it all blow hard , with pedigree from CYDY…
Please show more respect to Jay, he does not deserve your vitriol…

[tmoney2555]

I appreciate your post. At times I become very frustrated and fall down the FDA conspiracy rabbit hole. It’s nice to be pulled away from those thoughts and keep an open mind about Lenz EUA.

[kairos]

The FDA is a captured regulatory agency:

Regulatory capture is defined as when a supposedly objective regulatory agency ends up promoting the ends of the industries they are regulating

they are the enemy and I don't care if that doesn't help HGEN's cause because this is a much bigger issue and these criminals need to be held accountable

https://www.theamericanconservative.com/articles/the-regulatory-capture-of-the-fda/

[papaphilip]

Don Cubed, I enjoy and respect both your an CJ’s posts. I’m glad you both express yourselves. In your post you wrote “Lenz is the most efficacious drug for newly hospitalized Covid patients.” If you and most of us believe that, you can surely understand why we are all frustrated with the FDA. Now we obviously have no power to do anything, and directly complaining to them may in fact hurt our cause (eg CYDY), but collectively voicing our frustration, distrust, and assumed collusion by them against HGEN and Lenz is a reasonable response and a understandable release. I mean if we are ‘the most efficacious drug” it should be known by now and an EUA issued. It’s an EUA for crying out loud, not full approval, and if deemed not so ‘efficacious’ later, they could always pull the EUA. That’s been done before. They’re just delaying getting us started in helping patients. So we remain pissed off and losing patience, but also hopeful, wanting what’s best for patients first, then the company and ourselves.

[MWM]

And if you believe what you post, Lenz is the most efficacious drug then your explanation for why Lenz is past day 100 sucks.
The FDA and NIH are two separate entities and I know for a fact that sometimes they don’t see eye to eye. No explanation has been sent to Humanigen as to why we are past 100 days. EUA’s are granted in times like this when safety and efficacy have been proven which they have.
I’ve never said it’s a conspiracy, it’s just not a priority for the fda to rule. They don’t expedite smaller companies because they are clearly not a priority, smaller companies have to wait in line even to be turned down.
What we are seeing is plain and simply a big Pharma bias. If there wasn’t a bias then at a bare minimum the fda would have sent some type of communication by now.

We have better data than any drug on the market for Covid. I’ll continue to hound the fda until we are approved!
Pump Pump Pump Pump I Shall, sorry little Donnie…

[Neophius]

Anger is the appropriate response when measured against the failure the FDA has shown.

No communication with HGEN. None. No additional data needed.

We’ve met all criteria for a EUA. Multiple credentialed sources are surprised this hasn’t been approved already.

Your theory concerning the FDA being a positive actor is motivated purely out of defensive fear; you need to believe that the FDA will absolutely do the right thing.

I’m looking at reality and preparing myself that the FDA is possibly going to act in a corrupt manner. Let the UK have their say if the US drops the ball.

[cowtown jay]

I didn't see this post initially. I keep going back and forth about whether I want to see your posts, or not. I would really rather see them, especially when I only see a dozen or two posts all day on occasion, but we just don't quite seem to be on the same wavelength sometimes, and I get frustrated.

There are two topics where this issue has manifested. One is in regards to the different performance matrices that appear in the slide decks. You argue specifically that there were patients in both arms of the ITT and mITT population that never received either lenz or a placebo. That's the only argument that applies going forward.

Because I'm glad to see that you and I agree on the more important matrices, "Baseline CRP < 150, Age < 85* and Survival without Ventilation." This is the matrix that reflects the 2.96 Hazard Ratio, and the p value of 0.0003.

Also, "Remdesivir + Baseline CRP < 150, Age < 85*," with a Hazard Ratio of 3.22, with a p value of 0.0002.

slides 16 and 17
https://s28.q4cdn.com/539885110/files/doc_presentations/2021/August/HGEN-August-Corporate-Presentation.pdf

You don't seen to have the same apprehensions in regards to the number of reported ITT and mITT patients.

Is that because you recognize the exclusions of 12 lenz and 10 placebo patients, as part of the 41 total exclusions?

Regardless, I'm glad to see you express the significance of that data, although with those p values, I can't agree with the need for additional trial information. Maybe so, under normal circumstances, but not in the current environment

Hence, the second topic. I don't think I have been near as responsible for pushing a negative narrative against the FDA as to justify a push against me. But that is a very small matter. I was only more conciliatory toward the FDA after I said I would wait to see if we had an EUA after Labor Day.

I did try to give the benefit of doubt to the FDA, by suggesting that they may have wanted to avoid impacting the placebo population of the NIH trial.

And again, when I blame management's failure to publish peer reviews as a reason for the FDA to claim difficulty in evaluating lenzilumab's benefit.

But the bottom line is, in truth, it is unconscionable to delay treating these Covid patients with this drug that I think will be unsurpassed in the ability to save their lives.

To decline our approval is to cast doubt on lenzilumab's benefit, and to run this company into a wall just as we were set to establish a revenue stream, and enhance our CMC capabilities, which are now threatened, and pose a deepening development of that threat as each day goes by.

It only takes one regulatory approval to restore our potential, which I don't think has been diminished...yet.

Twenty years ago, today, this country was shaken to its core by the 2,977 deaths on 9-11.

Now, we can call that level of destruction 'Friday.'

Total deaths 660,424
New (on Sep 10): +2,502
Change (7 day avg):
(this week vs last week) +5.7%

https://newsnodes.com/us

[jjson]

Don't get me wrong, I'm long HGEN, but just making some assumptions.

What if NIH is thinking the same thing as FDA?
After getting data from 200 patients, they weren't sure if the benefit outweigh the risks.
So they wanted to take a deeper look and increased more enrollment.
They wanted to give it a shot because most of their ACTIV trials has failed or terminated.

Is there a possibility that this assumption may be true?