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Posted On: 03/29/2021 9:05:59 AM
Post# of 154141
Rough notes
03-29-2021 NeuroRx Con Call
Houston Methodist Hosptial
Dr. Youseff
Starting EUA process this week
Going forward
Not large BP
Tertiary care hospitals was different than regional hospitals
200% ICU over capacity in regional hospitals
As ICU capacity nears 100% COVID mortality increases
Zyesami has some anti-viral properties
But is main MOA is helping the lungs
COVID attacks aleoli cells
COVID attacks these vulnerable cells that attack the surfactant
What comes next:
Zyesami p2/3 as inhaled drug
Zyesami working with US gov’t in two trials
FDA has approved the inclusion of Zyesami in these two trials
DEX was an open label trial
Zyesami was 1st drug (i.e. didn’t think LL) demonstrated stat and clinically sig. in Critical COVID
“Covid Lungs” – chronic lung injury
Smoke inhalation also causes this
Plan to do trials related to this.
Cystic fibrosis
Pulmonary fibrosis (1/2 die within 3-5 years)
******
Q&A:
June Li, Truest
Q: Primary Endpoint, what does it entail
Time to discharge
Quality of Life assessments
A: FDA stated as “respiratory failure” is a resource based definition = in RF if you require HFNO2 or non-invasive or mech. Ventilation (it is not a clinical criteria).
Did not include QOL assessments in study, many pts were in ICU and unconscious – QOL is not viable.
Longer hospital stays for placebo group.
Q: Plans to meet with FDA, timing?
A: Plan to meet with FDA asap. In general, meetings and correspondence are private. As soon as have met, determinations made, then should expect to hear about them.
Q: # of pts that might qualify for this drug (respiratory failure)?
A: Hopefully, fewer and fewer in coming years. But right now, hundreds of thousands of pts around the world.
Pricing = within the price range that ICUs consider to be quite reasonable.
Drugs currently used for high single digit thousands
Some anti cytokine drugs that are more expenisive
Plan is to have reasonable pricing
****
Need to work on refrigerator stable version of Zyesami; sounds like a gating factor for approval of the drug.
03-29-2021 NeuroRx Con Call
Houston Methodist Hosptial
Dr. Youseff
Starting EUA process this week
Going forward
Not large BP
Tertiary care hospitals was different than regional hospitals
200% ICU over capacity in regional hospitals
As ICU capacity nears 100% COVID mortality increases
Zyesami has some anti-viral properties
But is main MOA is helping the lungs
COVID attacks aleoli cells
COVID attacks these vulnerable cells that attack the surfactant
What comes next:
Zyesami p2/3 as inhaled drug
Zyesami working with US gov’t in two trials
FDA has approved the inclusion of Zyesami in these two trials
DEX was an open label trial
Zyesami was 1st drug (i.e. didn’t think LL) demonstrated stat and clinically sig. in Critical COVID
“Covid Lungs” – chronic lung injury
Smoke inhalation also causes this
Plan to do trials related to this.
Cystic fibrosis
Pulmonary fibrosis (1/2 die within 3-5 years)
******
Q&A:
June Li, Truest
Q: Primary Endpoint, what does it entail
Time to discharge
Quality of Life assessments
A: FDA stated as “respiratory failure” is a resource based definition = in RF if you require HFNO2 or non-invasive or mech. Ventilation (it is not a clinical criteria).
Did not include QOL assessments in study, many pts were in ICU and unconscious – QOL is not viable.
Longer hospital stays for placebo group.
Q: Plans to meet with FDA, timing?
A: Plan to meet with FDA asap. In general, meetings and correspondence are private. As soon as have met, determinations made, then should expect to hear about them.
Q: # of pts that might qualify for this drug (respiratory failure)?
A: Hopefully, fewer and fewer in coming years. But right now, hundreds of thousands of pts around the world.
Pricing = within the price range that ICUs consider to be quite reasonable.
Drugs currently used for high single digit thousands
Some anti cytokine drugs that are more expenisive
Plan is to have reasonable pricing
****
Need to work on refrigerator stable version of Zyesami; sounds like a gating factor for approval of the drug.
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