Given that there are a lot of info to digest and non-clarity from the 2 PRs and Dr. Been interview, I submitted below questions to the company to address in tomorrow investors' call. Curious to what questions you will/have sent:
1. Did Janet Woodcock specifically mention in the meeting that FDA will not consider EUA even after Cytodyn presented the age-adjusted analyses on primary and secondary endpoints for severe and critical population?
2. Did FDA request follow-up data on 60-day mortality and secondary endpoints?
3. In the new critically-ill protocol submitted to FDA, what is the target population, i.e. age below 65 and on mechanical ventilation?
4. What is the age-adjusted result on 28-day mortality in only severe population?
5. What is the age-adjusted result on 28-day mortality in subgroup comparing Leronlimab + antiviral vs. antiviral alone?
6. What is the age-adjusted result on 28-day mortality in subgroup excluding immunosuppressors like Dexamethasone? There is benefit of Leronlimab on top of Dex compared to Dex alone.
7. What is the proportion of pts who progressed from severe to critical in Leronlimab + standard care vs. standard care alone?
8. Does the 62 pts represent all critical pts or just subset of mechanically ventilated critical pts?
9. What are the number of deaths in each treatment arm for each of severe and critical population? Same question on age subgroups above 65 and below?
10. Will Cytodyn file for interim order in Canada in each of severe and critical populations? How about the moderate population given the results from CD-10?
11. Will MHRA consider EUA after Cytodyn presented age-adjusted analyses and the additional results from 46 pts in open-label portion of CD-12?
12. Did Cytodyn start selling Leronlimab in Philippines under compassionate use?
13. What other countries will Cytodyn send CD-12 top line results besides US, UK, Canada, Philippines and Brazil?
14. What countries had approached Cytodyn to sell Leronlimab without requiring EUA from US FDA?
15. What are the timelines on non-Covid trials, i.e. NASH, mTNBC and basket cancer trials?
16. Will Cytodyn consider trials for additional indications in 2021, for example stroke, MS and Alzheimer’s?
1. Did Janet Woodcock specifically mention in the meeting that FDA will not consider EUA even after Cytodyn presented the age-adjusted analyses on primary and secondary endpoints for severe and critical population?
2. Did FDA request follow-up data on 60-day mortality and secondary endpoints?
3. In the new critically-ill protocol submitted to FDA, what is the target population, i.e. age below 65 and on mechanical ventilation?
4. What is the age-adjusted result on 28-day mortality in only severe population?
5. What is the age-adjusted result on 28-day mortality in subgroup comparing Leronlimab + antiviral vs. antiviral alone?
6. What is the age-adjusted result on 28-day mortality in subgroup excluding immunosuppressors like Dexamethasone? There is benefit of Leronlimab on top of Dex compared to Dex alone.
7. What is the proportion of pts who progressed from severe to critical in Leronlimab + standard care vs. standard care alone?
8. Does the 62 pts represent all critical pts or just subset of mechanically ventilated critical pts?
9. What are the number of deaths in each treatment arm for each of severe and critical population? Same question on age subgroups above 65 and below?
10. Will Cytodyn file for interim order in Canada in each of severe and critical populations? How about the moderate population given the results from CD-10?
11. Will MHRA consider EUA after Cytodyn presented age-adjusted analyses and the additional results from 46 pts in open-label portion of CD-12?
12. Did Cytodyn start selling Leronlimab in Philippines under compassionate use?
13. What other countries will Cytodyn send CD-12 top line results besides US, UK, Canada, Philippines and Brazil?
14. What countries had approached Cytodyn to sell Leronlimab without requiring EUA from US FDA?
15. What are the timelines on non-Covid trials, i.e. NASH, mTNBC and basket cancer trials?
16. Will Cytodyn consider trials for additional indications in 2021, for example stroke, MS and Alzheimer’s?
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