this is what hitekmastr wrote re cc JULY 30 CON
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Posted On: 07/30/2020 8:04:04 PM
this is what hitekmastr wrote re cc
JULY 30 CONF CALL - 14 TAKEAWAYS
1. EFFICACY/DATA – CYDY said they have very positive results and improvement in days 3, 7 and 14, and the magnitude should be better than Remdesovir. A press release on efficacy endpoints will be forthcoming. A major journal article will be published quickly after the PR. Full top line efficacy data is due in 10 DAYS.
2. COMPETITION – Multiple therapies will be needed so there will be a place for Leronlimab. Vaccines will NOT end the need for therapeutics. Most antibody vaccines will be transient (not permanent) plus many people will wait to take vaccines until proven. Less than 9 percent of the US population has been infected so there is a risk of many more infections before vaccines shut down the pandemic.
3. CD 10 Trial (Moderate Disease Group) – Top line efficacy data is expected in 10 days which will be published in PR and articles immediately and in detail.
4. CD 12 Trial (Strong Disease Group) – 165 Patients are enrolled in CD12, interim efficacy analysis will be conducted when they reach 195 patients. The Data Safety Monitoring Committee meets Aug 3 with Safety results expected NEXT WEEK.
5. Newest Indications – MS and Alzheimer’s trials are planned.
6. The first NASH patient will be injected in SEPTEMBER.
7. HIV BLA Submission – Should know the FDA meeting date next week. The Meeting discussion will include approval of Leronlimab as an HIV MONOTHERAPY. (Note: Nearly all HIV patients in trials have NOT contracted COVID but this is not applicable to the COVID trial analysis.)
8. Financing – CytoDyn financed $25 Million for less than 3 million shares. Dr. P hopes to raise enough cash to fund CYDY thru 2022 with minimal or no dilution.
9. NASDAQ – Uplisting is underway. It’s a 6 week process. The 3rd to 4th week of August will be the earliest listing date, depending on questions/issues raised.
10. The 10K will be filed August 14.
11. After FDA approval for COVID19, government funding avenues will open.
12. Haven’t done any pediatric studies yet.
13. PATENTS are updated for all new indications. The existing composition of materials (PRO-140) patent gives the exclusive right for any indication for the term of the Leronlimab patent, with a 12 year time horizon.
14. Samsung production of Leronlimab vials – two lots, 500 and 600 vials will be available this year, plus 100,000 vials or more from AGC.
JULY 30 CONF CALL - 14 TAKEAWAYS
1. EFFICACY/DATA – CYDY said they have very positive results and improvement in days 3, 7 and 14, and the magnitude should be better than Remdesovir. A press release on efficacy endpoints will be forthcoming. A major journal article will be published quickly after the PR. Full top line efficacy data is due in 10 DAYS.
2. COMPETITION – Multiple therapies will be needed so there will be a place for Leronlimab. Vaccines will NOT end the need for therapeutics. Most antibody vaccines will be transient (not permanent) plus many people will wait to take vaccines until proven. Less than 9 percent of the US population has been infected so there is a risk of many more infections before vaccines shut down the pandemic.
3. CD 10 Trial (Moderate Disease Group) – Top line efficacy data is expected in 10 days which will be published in PR and articles immediately and in detail.
4. CD 12 Trial (Strong Disease Group) – 165 Patients are enrolled in CD12, interim efficacy analysis will be conducted when they reach 195 patients. The Data Safety Monitoring Committee meets Aug 3 with Safety results expected NEXT WEEK.
5. Newest Indications – MS and Alzheimer’s trials are planned.
6. The first NASH patient will be injected in SEPTEMBER.
7. HIV BLA Submission – Should know the FDA meeting date next week. The Meeting discussion will include approval of Leronlimab as an HIV MONOTHERAPY. (Note: Nearly all HIV patients in trials have NOT contracted COVID but this is not applicable to the COVID trial analysis.)
8. Financing – CytoDyn financed $25 Million for less than 3 million shares. Dr. P hopes to raise enough cash to fund CYDY thru 2022 with minimal or no dilution.
9. NASDAQ – Uplisting is underway. It’s a 6 week process. The 3rd to 4th week of August will be the earliest listing date, depending on questions/issues raised.
10. The 10K will be filed August 14.
11. After FDA approval for COVID19, government funding avenues will open.
12. Haven’t done any pediatric studies yet.
13. PATENTS are updated for all new indications. The existing composition of materials (PRO-140) patent gives the exclusive right for any indication for the term of the Leronlimab patent, with a 12 year time horizon.
14. Samsung production of Leronlimab vials – two lots, 500 and 600 vials will be available this year, plus 100,000 vials or more from AGC.
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