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OneDay4488

07/27/21 12:22 PM

#31474 RE: Scooter McCabe #31473

1. Kovacs left sometime ago, he was in a non-essential role. So his departure was not recent. Does he own shares to sell?

Neophius

07/27/21 12:24 PM

#31475 RE: Scooter McCabe #31473

This confirms what another person who spoke to IR said recently.

10nisman

07/27/21 12:53 PM

#31476 RE: Scooter McCabe #31473

1. Kovacs left sometime ago, he was in a non-essential role. So his departure was not recent.



Kovacs was Head of Public Policy at HGEN and previously held senior roles in private equity and investment banking, including at Blackstone Group, Citigroup, and the Hinduja Group.

One would think Kovacs would have been heavily involved in any M&A activities --- but then again, there were and are none and IR confirms this by saying he was in a "non-essential" role and his departure was not recent.

cowtown jay

07/27/21 2:38 PM

#31479 RE: Scooter McCabe #31473

It became somewhat incongruous on July 8th to expect the FDA to authorize lenz, and thereby demonstrate for all the world to see, that there is a schism in our government's health service agencies regarding something so significant as the best life-saving therapeutic candidate to treat a virus that has caused a worldwide pandemic.

If it was up to me, I would probably stop providing lenz to the NIH for their Activ5 trial.

I would appeal the NIH's finding that there was insufficient evidence for them to specifically recommend lenz as a GM-CSF inhibitor, and that Humanigen was treated unjustly by a collective determination which included inferior GM-CSF inhibitors.

I would dispute the Key Limitations they cited. Our study was powered to meet the evolving endpoint the FDA was recommending. I think the HHS OIG should look into why there were differences in supportive care in our study sites, and whether those differences should have resulted in a decrease of our Hazard Ratio rating.

https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/table-of-contents/

https://www.covid19treatmentguidelines.nih.gov/tables/table-4b/

The FDA should not be deterred in making a decision to approve an EUA for lenz, just because the Otilimab and Mavrilimumab mAbs collectivley caused the NIH to determine there was insufficient evidence to render a GM-CSF group recommendation.