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Re: dloggold post# 34959

Wednesday, 12/29/2021 7:30:44 PM

Wednesday, December 29, 2021 7:30:44 PM

Post# of 42497
I know you well enough to know that you COULD very well have reason to believe that Clinigen won't do much for us.

But I have no such reason.

What else is there? Evusheld?

"...for the pre-exposure prophylaxis of coronavirus disease 2019...Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARSCoV-2..."

https://www.fda.gov/media/154701/download

Paxlovid?

The trial, "...enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness...PAXLOVID can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease."

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-receives-us-fda-emergency-use-authorization-novel

Molnupiravir?

Not authorized, "...for initiation of treatment in patients hospitalized due to COVID-19..."

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

Sotrovimab?

"Sotrovimab is not authorized for use in patients:
o who are hospitalized due to COVID-19, OR
o who require oxygen therapy due to COVID-19, OR
o who require an increase in baseline oxygen flow rate due to COVID-19"

https://www.fda.gov/media/149534/download

Lilly mAb cocktail?

"Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19."

https://www.covid19.lilly.com/bam-ete/hcp

Besides, the FDA has shelved their product.

REGEN-COV?

"...not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen..."

https://www.regencov.com/

The FDA has also shelved Regen-Cov.

https://cbsaustin.com/news/local/two-of-three-monoclonal-antibody-covid-19-treatments-not-effective-against-omicron

Lenz is the only real therapeutic to treat hospitalized and hypoxic patients, who have a baseline CRP of <150mg/L (which represented about 80 % of our LIVE-AIR trial patients, and should represent about 400 of the ACTIV-5 NIH trial patients). Toci is suggested to treat hospitalized patients with CRP> 175mg/L, as I recall. That is not a patient population that HGEN wants to use their limited product to treat. I can't believe we haven't already sold every vial of lenz that we have.