Humanigen Inc【HGEN】株式ニュース

Bump.

Marty, please, you have to be aware of how your own comments serve to exasperate the very failures of the FDA that you lament.

Let me share my perspective on what you said here: “We have a bit of a public trust problem,” Makary said. “I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”

I passionately agree with you that there is a public trust problem in the FDA. Let me get case specific here as it relates to my investment in Humanigen, and my faith in their Lenzilumab (lenz) leading drug candidate. The void in our safety and efficacy data is because the FDA Declined to review our EUA request. My comments at the time were as follows.

"Posted by: cowtown jay
In reply to: None
Date: 01/10/2025 05:59:07 PM
Post #: 43,649 of 43,854
Vigilant Fox,

The FDA granted IND (corrected) authorization to treat covid for Humanigen's Lenzilumab on April 2, 2020, just weeks after the pandemic started. So by May of 2021, it is likely they had full knowledge of the outstanding safety and efficacy lenz demonstrated under this IND authorization.

https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx

Management communicated with the FDA during this year-long process, and the FDA knew the company was prepared to request an EUA based on their LIVE-AIR Phase III trial to treat hospitalized and hypoxic patients with covid pneumonia.

What did the FDA do? On May 25, 2021, "...The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:...As noted in the guidance, for the remainder of the current pandemic, the FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in the agency’s guidance, “Emergency Use Authorization Vaccines to Prevent COVID-19.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-25-2021

Three days later, May 28, 2021, "Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19." The FDA Declined to make a decision on our EUA application, based on their newly self-granted power to Decline to make a decision.

https://ir.humanigen.com/English/news/news-details/2021/-Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19/default.aspx

Lenz has the ability to program an appropriate immune response, which is also variant-agnostic. This poses a threat to a multi-billion dollar annuity revenue stream Big Pharma, who are major providers of government agencies' operating budgets, and grantors of royalties to government agencies' scientists, all currently enjoy."

https://investorshub.advfn.com/boards/manage_msg.asp?message_id=175649690

In addition, NIAID and the NIH conducted a "confirmatory" ACTIV-5 Bet B study of lenz. I voiced my opinion of that in expressing my reason for wanting no part of the litigation brought against the company in the Class Action suit.

"Re: [External]Exclusion from Litigation

Jay Booth

From:
jayatthelake2003@yahoo.com
To:
Ann Cavanaugh

Sat, Feb 3 at 6:15 PM

Dear Ms. Cavanaugh.

Your instruction that I must send a letter by mail, and that I must provide transaction details in Humanigen securities, to be excluded from litigation, impose requirements that I don't feel well enough to comply with. I will simply comply with page 2 of the Notice of Pendency:

"DO NOTHING Get no payment."

I strongly disagree with the Lead Counsel, as I have publicly declared in the following.

cowtown jay

Re: bencozey post# 41218

Tuesday, December 19, 2023 7:38:43 PM

Post#
41220
of 41817 Go
As the ACTIV-5 government-sponsored trial of lenzilumab was announced, I felt that it was nothing more than the commandeering of our successful LIVE-AIR trial results. A simple comparison of the trial designs prove that. Look at the patient inclusion criteria for the two trials.

The government-sponsored ACTIV-5 trial inclusion criteria #6:

"Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) (ordinal score 5, 6, or 7)."

https://clinicaltrials.gov/study/NCT04583969?intr=Lenzilumab&rank=2

The company-sponsored LIVE-AIR trial inclusion criteria:

"SpO2 ≤ 94% on room air and/or require low-flow supplemental oxygen and/or require high-flow oxygen support or NIPPV
Hospitalized, not requiring invasive mechanical ventilation during this hospitalization"

https://clinicaltrials.gov/study/NCT04351152?intr=Lenzilumab&rank=3

The government excluded room air patients in their trial, and included patients on IMV and ECMO. Humanigen did not intend to treat patients that were as seriously ill as the government included in their trial.

And in case you haven't seen just how successful the LIVE-AIR trial results were, here are the peer reviews from Lancet and Thorax on this page.

Humanigen, Inc.

I've been here since 2017. I know the company hoped that ACTIV-5 would corroborate our findings. But including patients in such a late-stage of disease progression in their trial, and excluding the room air patients who did so well in the LIVE-AIR trial, only demonstrates that ACTIV-5 was never going to corroborate the LIVE-AIR trial results.

Lenzilumab is going to be a blockbuster drug (generate over $1B in yearly revenue). Pfizer needs that revenue. But we don't need Pfizer, or any other Big Pharma, to capture this market potential. Durrant has already run 5 blockbuster products through the FDA validation process. And Dale is a specialist in the field of T cell memory function, having been published in his post-doctoral work with the Howard Hughes Medical Institute.

I have shown you the proof of what this management team has done. And I have demonstrated the government's effort to safeguard the revenue of their Big Pharma sponsors. Hopefully, facts will persuade you that the NIH and the FDA are the real culprits here, with the deadly abuse of their discretionary authority."

Thank you,
Jay Booth

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173768831

But, the government's deadly abuse of their discretionary authority doesn't stop there.

The FDA evidently told Humanigen's management that they were unlikely to approve the EUA. Keep in mind that the FDA ultimately Declined to even review the EUA application, despite positive peer reviews of the LIVE-AIR trial by both Lancet and Thorax publications. The FDA got the SEC and the DOJ to file charges for selling shares in the company despite the bogus concerns of the FDA, (except for the devastation it would cause their sponsors, Moderna and Pfizer).

"According to the SEC’s complaint, between June and August 2021, Chappell and Durrant sold Humanigen stock while in possession of material nonpublic information that the U.S. Food and Drug Administration was unlikely to approve Emergency Use Authorization (EUA) for Humanigen’s newly developed COVID-19 drug, lenzilumab."

https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26206

Do the right thing, Marty. Fill the data void you recognize by ordering your agency to Authorize or Approve lenz based on a review of the company's EUA request in 2021, and review the Lancet and Thorax peer reviews. Humanigen, it's shareholders, and patients, deserve the benefit of the paradigm shift lenz has facilitated as part of Generation Gold Standard, which I think it is. Approve the Novavax vaccine in accordance with the postmarketing commitment.