CYDY notes from the recent CC on March 22, 2021 wi
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Posted On: 03/26/2021 3:09:08 PM
CYDY notes from the recent CC on March 22, 2021 with approximate timings
NOT A TRANSCRIPT
Some points are highlighted, but all could be.
1. 4:30 There have been approximately 3000 clinical trials for covid19. Most have failed. 5% have been randomized and adequately powered. We believe we have a clear path forward and are working very closely with regulatory agencies throughout the world.
2. 5:13 Despite 124 million vaccinations administered in the United States, Covid19 cases have risen in 21 states and the infection rate has plateaued. The problem we are now facing is the variants.
3. 6:06 We believe leronlimab is not dependent on whether the virus is the wild-type virus or a variant. Our target is not the virus... Our goal is to restore immune function in the sickest Covid19 patients.
4. 6:33 We learned from CD12 that leronlimab has the potential to be synergistic with other medications, and leronlimab was well tolerated with no new safety signals.
5. 6:45 Our potential is not limited to the United States. We are moving forward with all opportunities, both domestically and internationally.
6. 7:27 mITT (modified Intent to Treat) are the 384 dosed patients of the 394 enrolled (ITT).
7. 7:40 CD12 trial Critical cases population, which was a pre-specified group, had 24% less mortality with leronlimab.
8. 8:37 Age stratification in cd12 trial happened to be against leronlimab by chance. Over age 65 patients happened to be in a 3:1 ratio in the leronlimab arm vs. the control arm.
9. 9:09 We did age adjustment as is appropriate and is allowed by regulatory agency and we realized that we are actually statistically significant or very close to being statistically significant in a few areas amongst severe or amongst critical populations. But this is called sub-population analysis, and regulatory agencies do not give approval in this kind of analysis. But since we are in a pandemic, we are hoping that we can perhaps get a conditional emergency use authorization while we continue to generate more data for regulatory agencies in several different countries, including the United States.
10. 10:17 Emergency Use Authorization- You file a request with the FDA. “We did that and we also told the FDA at the very beginning, here’s our executive summary. The FDA said that these results are good enough to allow you to continue with another trial to get more data for critical population.”
11. 11:05 “We then filed a request for conditional EUA. Formally. We asked the agency to allow us to have a conditional emergency use authorization while we get more data from another trial which is we call CD16. However, after our scientists all elaborated on certain items, we believe that we should do 2 different trials. One CD16 for below 65 to get approval and emergency use authorization and hit our P value hopefully. For under 65 we saw great results in our study across severe critical sub population.” “That protocol has been submitted to the FDA as of this morning and once the FDA has OK’d that we will immediately start that.”
12. 12:10 But we also told the agency we would do a protocol for over 65 but not with subQ, but with IV as a first dose, and perhaps 2 extra dose. That makes it 3 doses versus 2 doses, but the next 2 doses will be subQ perhaps. We would like to have time to discuss that with the agency while our CD16 will immediately start.
13. 12:35 We also have currently open label arm of a cd12 study which allows us to enroll patients in an open label of CD12.
14. 12:50 United States- We formally have asked for conditional emergency use authorization. Filed our request with the FDA.
15. 13:05 UK- MHRA met with us on March 4, 2021. The said you should file for accelerated rolling review and we will grant it to you. We are in the process of going forward with them in this regard.
16. 13:27 Europe- EMA. We are preparing a request to meet with EMA to discuss fast approval of leronlimab with EMA. We plan to submit this as soon as possible.
17. 13:45 Canada- We have submitted the timeline which is the first part of filing your Interim Order, which is similar to EUA in the United States. “We have requested Health Canada’s authorization for import and sale of leronlimab in Canada”.
18. 14:12 Philippines- The group in Philippines are working with another hospital now to be able to get the first patient injected CSP (similar to US eIND). Once we get 5 or 10 patients we believe our case of getting EUA in Philippines will become much stronger. The team in Philippines is also looking at CSP for long-haulers or other participation in trial.
19. 15:10 Brazil- Working to identify MAH (marketing authorization holder). Working to submit a meeting request and package to the Brazilian health regulatory agency ASAP because we know the situation in Brazil is not very good.
20. 15:46 Hungary Ministry of Health requested Cytodyn send them a summary of leronlimab past data. We expect to send the presentation and executive summary by tomorrow (March 23).
21. 16.15 OLE CD12 51 patients. Results are good.
22. 17:35 HIV- wants to file with FDA, MHRA, EMA, and Health Canada for approval for HIV. Upcoming April 7 meeting with FDA to file for Samsung as manufacturer. Believe we can submit the dose justification by hopefully first part of May and if no problem will move forward with submitting whole BLA. Keep in mind that there was also an issue with the receptor occupancy test. A test is being developed right now and believe we can get this done by June/July timeframe. Health Canada has not requested the receptor occupancy and we are meeting with them in mid-April. A filing in Canada, equivalent to US FDA BLA may happen first. A US BLA filing might happen in June/July but there will be updates along the way before then.
23. 20.05 Cancer/NASH- want to meet with FDA for pre-breakthrough discussion. NASH has 30% enrollment and hope to complete enrollment this year. Asked for rolling review and may be able to submit as early as in 1 ½ months.
24. 22:09 Results of long haulers trial may be as soon as 6 weeks or maximum in 8-9 weeks. Might look at data in 1st week of May which is week 4 of observation.
25. 24:25 We think the virus is going along the olfactory nerve into the cribriform plate and entering the central nervous system. We know from animal studies that leronlimab crosses the blood brain barrier and attaches to the CCR5 receptor with approximately 70-75% receptor occupancy. Our feeling is that if we can control the neuro-inflammation we can help with the cognitive impairment, but there is also the whole issue of autonomic symptoms that we believe we can help with as well.
26. 25:30 Rahman on HIV BLA. Some vendors and labs were a little slow because there was a reduced number of staff in the lab due to covid. He has confidence in the way it is progressing and that they will submit a very high quality BLA.
27. 27:45 I want to make sure that everybody knows that Leronlimab, when we administer it, it gives us 100% occupancy of the receptor. In contrast Maraviroc was told to us that does about 40 or 50%. This it from our consultant who has worked on it and is working right now on receptor occupancy.
28. 28:31 US FDA conditional EUA submitted for Covid19 “about 10 days ago” (ie. about March 12)
29. 28:40 after CD12, the receptor occupancy test of the past was noticed to be less than 50% accurate.
30. 30:10 The FDA has not indicated additional HIV studies are necessary. They said very clearly that you have rolling review given to you to submit your BLA. They gave a refuse to file and said nothing about another trial but said that work was needed on the dose justification to be in the way they want it presented, and that the receptor occupancy was not well done so that they wanted that to be taken care of. We are doing all of that. Keep in mind that we will get a 30-day turnaround on FDA looking at their packet to guide Cytodyn through any deficiencies so that the package is perfect before Cytodyn will officially submit the packet.
31. 32:23 Receptor occupancy for Health Canada submission is not needed as of right now. If that changes, we will let you know. We update shareholders a lot because we are a small company.
32. 32:45 Still unknown if can sell leronlimab in Canada while Interim Order application is under review. May receive an answer once the IO application is filed. CNC timeline was provided, the non-clinical package will be finished in a few days, and clinical data executive summary is already there. Will be doing CD16 in Canada as well.
33. 33:58 FDA conditional EUA request was filed after listening to our scientific team & Amarex.
34. 35:15 We do not need separate trials for the variants. Leronlimab will not be affected by the variants because of the target. That is our advantage.
35. 35:57 HIV BLA- the non-clinical portion is getting very close to being done.
36. 39:51 Longhauler & NASH trials enrollments are done through Amarex. All of are trials are going through the CRO, Amarex.
37. 46:42 Rahman- If the primary endpoint is not met, then they consider sub-group analysis as exploratory and they do not want to give approval based on that. If the primary endpoint was positive, then we could get additional indications based on the sub-group analysis. So that’s how it works. Its not that FDA has something against us, its just that that are the rules, the statistical and regulatory rules.
38. 49: 00 Will submit OLE data to agencies.
39. 50:00 FDA wanted longhaulers trial at 50 patients.
40. 54:24 The company’s clinical trial efforts are setup to eliminate potential sources of bias that could possibly occur at its clinical trial sites. Neither Dr. Chris Recknor nor his wife who owns the site used to conduct some of our trials, and currently being used as one of the sites for our NASH and Covid19 longhauler trial are involved in any company clinical trials at this site, and… does not see, has not treated and will not treat any patients at these sites for the clinical trials. The company has also determined that the financial terms of its relationship with the Center for Advanced Research and Education, this site, which pre-dated Dr. Recknor’s appointment as Chief Operating Officer of our company, are comparable to the terms available to other unrelated 3rd party sites, and it is in the best interest of the company to continue working with this site.
41. 56:18 After we got FDA greenlight for CD16, we changed our approach and wanted to split it into 2 trials. One for under 65 (2 subQ doses), and one for over 65 (IV first then 2 subQ doses). It was 100% ready to go but now we want to wait to make sure the FDA is OK with the change.
42. 57:00 Primary endpoint for CD16 is patients are alive and free from respiratory failure. We have high chance of hitting the primary endpoint, and because of the delta we are able to keep the trial size down.
43. 58:35 Will have interim analysis of CD16 and will have DSMC look at that. If interim results p-value is statistically significant MHRA will (accept?) that. Pretty sure the FDA will too.
44. 59:45 CD16 comparison will be
SOC + placebo
vs.
SOC + leronlimab
We are not excluding anything or specifying anything as standard of care (SOC). SOC will be whatever the institution or hospital uses.
45. 1:00:50 Late April presentation at TNBC digital summit. Talking about Mechanism of Action of leronlimab and the tumor micro-environment. Expecting a lot of recognition.
46. 1:01:39 We are reading very powerful statements from patients who have contacted Dr. Kelly. The number of patients with testimonies of good results is really enjoyable to see.
47. 1:03:25 uplisting
48. 1:10:38 Doctor of LA patient called us because patient was very happy and thankful. The patient offered any kind of help to Cytodyn. We may work with him perhaps on certain things.
49. 1:11:49 Will soon request a meeting for Cancer pre-breakthrough designation. Have told Amarex to prepare that.
50. 1:12:06 I think that the future of cancer treatment is immunotherapy, and for a long time people didn’t want to accept that inflammation was a part of tumor growth and a crucial component to cancer progression. But I think now things are really really changing and (1:12:34) I think Oncologists are now focused on controlling the tumor micro-environment and I think that is where we have the most impact. You know this is based on strong science.
51. 1:12:42 We’ve looked at the tumors, we could see in the tumor micro-environment that the inflammatory cells were loaded with CCR5. We also did animal studies at the Cleveland Clinic. We showed a statistically significant inhibition of colon cancer metastasis to both the liver and the lungs.
52. 1:13:01 We also saw something very interesting in that study where we saw a decrease in angiogenesis and when you look at the pictures its pretty remarkable. Without a new blood supply these tumors can’t grow so we are very excited about that.
53. 1:13:15 We did another study which showed a reduction of more than 97%, the incidence of human breast cancer metastasis in a mouse model.
54. 1:13:25 But this is where I think it gets really interesting and is why I believe that the future of Cytodyn is oncology. You know we started going in to patients, and what we started seeing is;
one, there is no strong safety signals in these cancer patients and
two, these patients would tell me “I would rather die than go through chemotherapy again, I’m just not doing it”.
They are asking for more drug and would like to continue with Leronlimab.
55. 1:14:06 This is multiple different cancers that we’re starting to have some, again anecdotal, but some positive signs that we’re very excited about… go look at all the other researchers around the world and see what they are saying about CCR5 and oncology, metastasis, and the tumor micro-environment.
56. 1:14:30 Critical Covid19 cases market size pales in comparison to Long-haulers and that absolutely pales in comparison to 22 different solid tumor cancers. I think cancer definitely is the future of Cytodyn.
57. 1:16:07 Transcribing our calls would cost us quite a bit so we are not looking at that at this time.
58. 1:17:07 With leronlimab what we have seen is [in the Covid19] critically ill patient population, no other compound has shown that kind of result.
59. 1:18:31 30-40% of all the cases of Covid19 will probably have some degree of longhauler symptoms.
60. 1:19:10 management team, history
61. 1:23:33 sepsis
62. 1:24:48 Covid19, HIV, Cancer
63. 1:26:00 production- Samsung is still comfortable with us and has assured us they will make any amount of product we want. We feel strong about Samsung.
64. 1:27:10 We are in discussions with people are considering paying for trials where we only supply leronlimab and a few other things in multiple countries. We are very excited about that and think that it is a sign that people are believing in our drug and it’s safety.
65. 1:28:10 Patients could perhaps transfer to a hospital with a trial even if they are from another state and might be enrolled if they qualify with the inclusion criteria of the trial.
66. 1:29:44 vials- Samsung could produce millions of vials a month. Right now we have about 500,000 vials, bulk product for 600,000 vials, and some from the past. The total number comes to about 1.3 million vials that we could have available if we are trying to sell.
67. 1:31:10 Operation Warp Speed- I believe, but can’t confirm 100%, that all the possibilities are there as long as we get an EUA. We have talked with them before and that is what they indicated.
68. 1:31:50 CD16 is our focus to get approval for Covid19. We have green light from FDA to go forward, but made a change and sent to the FDA this morning (March 22) and await their response.
69. 1:32:39 Longhaulers- We are so close to getting answers. I’m very very excited and I hope shareholders are sharing in the excitement.
SOME RELATED LINKS
• March 22, 2021 conference call link to listen
https://www.cytodyn.com/investors/news-events...ty-webcast
• March 8, 2021 SEC 8K with executive summary & graphs of CD12 trial data Covid19 critical cases 2021.03.08
https://www.sec.gov/Archives/edgar/data/11756...dex991.htm
• March 8, 2021 conference call notes (Not a transcript)
https://investorshangout.com/post/view?id=6080669
NOT A TRANSCRIPT
Some points are highlighted, but all could be.
1. 4:30 There have been approximately 3000 clinical trials for covid19. Most have failed. 5% have been randomized and adequately powered. We believe we have a clear path forward and are working very closely with regulatory agencies throughout the world.
2. 5:13 Despite 124 million vaccinations administered in the United States, Covid19 cases have risen in 21 states and the infection rate has plateaued. The problem we are now facing is the variants.
3. 6:06 We believe leronlimab is not dependent on whether the virus is the wild-type virus or a variant. Our target is not the virus... Our goal is to restore immune function in the sickest Covid19 patients.
4. 6:33 We learned from CD12 that leronlimab has the potential to be synergistic with other medications, and leronlimab was well tolerated with no new safety signals.
5. 6:45 Our potential is not limited to the United States. We are moving forward with all opportunities, both domestically and internationally.
6. 7:27 mITT (modified Intent to Treat) are the 384 dosed patients of the 394 enrolled (ITT).
7. 7:40 CD12 trial Critical cases population, which was a pre-specified group, had 24% less mortality with leronlimab.
8. 8:37 Age stratification in cd12 trial happened to be against leronlimab by chance. Over age 65 patients happened to be in a 3:1 ratio in the leronlimab arm vs. the control arm.
9. 9:09 We did age adjustment as is appropriate and is allowed by regulatory agency and we realized that we are actually statistically significant or very close to being statistically significant in a few areas amongst severe or amongst critical populations. But this is called sub-population analysis, and regulatory agencies do not give approval in this kind of analysis. But since we are in a pandemic, we are hoping that we can perhaps get a conditional emergency use authorization while we continue to generate more data for regulatory agencies in several different countries, including the United States.
10. 10:17 Emergency Use Authorization- You file a request with the FDA. “We did that and we also told the FDA at the very beginning, here’s our executive summary. The FDA said that these results are good enough to allow you to continue with another trial to get more data for critical population.”
11. 11:05 “We then filed a request for conditional EUA. Formally. We asked the agency to allow us to have a conditional emergency use authorization while we get more data from another trial which is we call CD16. However, after our scientists all elaborated on certain items, we believe that we should do 2 different trials. One CD16 for below 65 to get approval and emergency use authorization and hit our P value hopefully. For under 65 we saw great results in our study across severe critical sub population.” “That protocol has been submitted to the FDA as of this morning and once the FDA has OK’d that we will immediately start that.”
12. 12:10 But we also told the agency we would do a protocol for over 65 but not with subQ, but with IV as a first dose, and perhaps 2 extra dose. That makes it 3 doses versus 2 doses, but the next 2 doses will be subQ perhaps. We would like to have time to discuss that with the agency while our CD16 will immediately start.
13. 12:35 We also have currently open label arm of a cd12 study which allows us to enroll patients in an open label of CD12.
14. 12:50 United States- We formally have asked for conditional emergency use authorization. Filed our request with the FDA.
15. 13:05 UK- MHRA met with us on March 4, 2021. The said you should file for accelerated rolling review and we will grant it to you. We are in the process of going forward with them in this regard.
16. 13:27 Europe- EMA. We are preparing a request to meet with EMA to discuss fast approval of leronlimab with EMA. We plan to submit this as soon as possible.
17. 13:45 Canada- We have submitted the timeline which is the first part of filing your Interim Order, which is similar to EUA in the United States. “We have requested Health Canada’s authorization for import and sale of leronlimab in Canada”.
18. 14:12 Philippines- The group in Philippines are working with another hospital now to be able to get the first patient injected CSP (similar to US eIND). Once we get 5 or 10 patients we believe our case of getting EUA in Philippines will become much stronger. The team in Philippines is also looking at CSP for long-haulers or other participation in trial.
19. 15:10 Brazil- Working to identify MAH (marketing authorization holder). Working to submit a meeting request and package to the Brazilian health regulatory agency ASAP because we know the situation in Brazil is not very good.
20. 15:46 Hungary Ministry of Health requested Cytodyn send them a summary of leronlimab past data. We expect to send the presentation and executive summary by tomorrow (March 23).
21. 16.15 OLE CD12 51 patients. Results are good.
22. 17:35 HIV- wants to file with FDA, MHRA, EMA, and Health Canada for approval for HIV. Upcoming April 7 meeting with FDA to file for Samsung as manufacturer. Believe we can submit the dose justification by hopefully first part of May and if no problem will move forward with submitting whole BLA. Keep in mind that there was also an issue with the receptor occupancy test. A test is being developed right now and believe we can get this done by June/July timeframe. Health Canada has not requested the receptor occupancy and we are meeting with them in mid-April. A filing in Canada, equivalent to US FDA BLA may happen first. A US BLA filing might happen in June/July but there will be updates along the way before then.
23. 20.05 Cancer/NASH- want to meet with FDA for pre-breakthrough discussion. NASH has 30% enrollment and hope to complete enrollment this year. Asked for rolling review and may be able to submit as early as in 1 ½ months.
24. 22:09 Results of long haulers trial may be as soon as 6 weeks or maximum in 8-9 weeks. Might look at data in 1st week of May which is week 4 of observation.
25. 24:25 We think the virus is going along the olfactory nerve into the cribriform plate and entering the central nervous system. We know from animal studies that leronlimab crosses the blood brain barrier and attaches to the CCR5 receptor with approximately 70-75% receptor occupancy. Our feeling is that if we can control the neuro-inflammation we can help with the cognitive impairment, but there is also the whole issue of autonomic symptoms that we believe we can help with as well.
26. 25:30 Rahman on HIV BLA. Some vendors and labs were a little slow because there was a reduced number of staff in the lab due to covid. He has confidence in the way it is progressing and that they will submit a very high quality BLA.
27. 27:45 I want to make sure that everybody knows that Leronlimab, when we administer it, it gives us 100% occupancy of the receptor. In contrast Maraviroc was told to us that does about 40 or 50%. This it from our consultant who has worked on it and is working right now on receptor occupancy.
28. 28:31 US FDA conditional EUA submitted for Covid19 “about 10 days ago” (ie. about March 12)
29. 28:40 after CD12, the receptor occupancy test of the past was noticed to be less than 50% accurate.
30. 30:10 The FDA has not indicated additional HIV studies are necessary. They said very clearly that you have rolling review given to you to submit your BLA. They gave a refuse to file and said nothing about another trial but said that work was needed on the dose justification to be in the way they want it presented, and that the receptor occupancy was not well done so that they wanted that to be taken care of. We are doing all of that. Keep in mind that we will get a 30-day turnaround on FDA looking at their packet to guide Cytodyn through any deficiencies so that the package is perfect before Cytodyn will officially submit the packet.
31. 32:23 Receptor occupancy for Health Canada submission is not needed as of right now. If that changes, we will let you know. We update shareholders a lot because we are a small company.
32. 32:45 Still unknown if can sell leronlimab in Canada while Interim Order application is under review. May receive an answer once the IO application is filed. CNC timeline was provided, the non-clinical package will be finished in a few days, and clinical data executive summary is already there. Will be doing CD16 in Canada as well.
33. 33:58 FDA conditional EUA request was filed after listening to our scientific team & Amarex.
34. 35:15 We do not need separate trials for the variants. Leronlimab will not be affected by the variants because of the target. That is our advantage.
35. 35:57 HIV BLA- the non-clinical portion is getting very close to being done.
36. 39:51 Longhauler & NASH trials enrollments are done through Amarex. All of are trials are going through the CRO, Amarex.
37. 46:42 Rahman- If the primary endpoint is not met, then they consider sub-group analysis as exploratory and they do not want to give approval based on that. If the primary endpoint was positive, then we could get additional indications based on the sub-group analysis. So that’s how it works. Its not that FDA has something against us, its just that that are the rules, the statistical and regulatory rules.
38. 49: 00 Will submit OLE data to agencies.
39. 50:00 FDA wanted longhaulers trial at 50 patients.
40. 54:24 The company’s clinical trial efforts are setup to eliminate potential sources of bias that could possibly occur at its clinical trial sites. Neither Dr. Chris Recknor nor his wife who owns the site used to conduct some of our trials, and currently being used as one of the sites for our NASH and Covid19 longhauler trial are involved in any company clinical trials at this site, and… does not see, has not treated and will not treat any patients at these sites for the clinical trials. The company has also determined that the financial terms of its relationship with the Center for Advanced Research and Education, this site, which pre-dated Dr. Recknor’s appointment as Chief Operating Officer of our company, are comparable to the terms available to other unrelated 3rd party sites, and it is in the best interest of the company to continue working with this site.
41. 56:18 After we got FDA greenlight for CD16, we changed our approach and wanted to split it into 2 trials. One for under 65 (2 subQ doses), and one for over 65 (IV first then 2 subQ doses). It was 100% ready to go but now we want to wait to make sure the FDA is OK with the change.
42. 57:00 Primary endpoint for CD16 is patients are alive and free from respiratory failure. We have high chance of hitting the primary endpoint, and because of the delta we are able to keep the trial size down.
43. 58:35 Will have interim analysis of CD16 and will have DSMC look at that. If interim results p-value is statistically significant MHRA will (accept?) that. Pretty sure the FDA will too.
44. 59:45 CD16 comparison will be
SOC + placebo
vs.
SOC + leronlimab
We are not excluding anything or specifying anything as standard of care (SOC). SOC will be whatever the institution or hospital uses.
45. 1:00:50 Late April presentation at TNBC digital summit. Talking about Mechanism of Action of leronlimab and the tumor micro-environment. Expecting a lot of recognition.
46. 1:01:39 We are reading very powerful statements from patients who have contacted Dr. Kelly. The number of patients with testimonies of good results is really enjoyable to see.
47. 1:03:25 uplisting
48. 1:10:38 Doctor of LA patient called us because patient was very happy and thankful. The patient offered any kind of help to Cytodyn. We may work with him perhaps on certain things.
49. 1:11:49 Will soon request a meeting for Cancer pre-breakthrough designation. Have told Amarex to prepare that.
50. 1:12:06 I think that the future of cancer treatment is immunotherapy, and for a long time people didn’t want to accept that inflammation was a part of tumor growth and a crucial component to cancer progression. But I think now things are really really changing and (1:12:34) I think Oncologists are now focused on controlling the tumor micro-environment and I think that is where we have the most impact. You know this is based on strong science.
51. 1:12:42 We’ve looked at the tumors, we could see in the tumor micro-environment that the inflammatory cells were loaded with CCR5. We also did animal studies at the Cleveland Clinic. We showed a statistically significant inhibition of colon cancer metastasis to both the liver and the lungs.
52. 1:13:01 We also saw something very interesting in that study where we saw a decrease in angiogenesis and when you look at the pictures its pretty remarkable. Without a new blood supply these tumors can’t grow so we are very excited about that.
53. 1:13:15 We did another study which showed a reduction of more than 97%, the incidence of human breast cancer metastasis in a mouse model.
54. 1:13:25 But this is where I think it gets really interesting and is why I believe that the future of Cytodyn is oncology. You know we started going in to patients, and what we started seeing is;
one, there is no strong safety signals in these cancer patients and
two, these patients would tell me “I would rather die than go through chemotherapy again, I’m just not doing it”.
They are asking for more drug and would like to continue with Leronlimab.
55. 1:14:06 This is multiple different cancers that we’re starting to have some, again anecdotal, but some positive signs that we’re very excited about… go look at all the other researchers around the world and see what they are saying about CCR5 and oncology, metastasis, and the tumor micro-environment.
56. 1:14:30 Critical Covid19 cases market size pales in comparison to Long-haulers and that absolutely pales in comparison to 22 different solid tumor cancers. I think cancer definitely is the future of Cytodyn.
57. 1:16:07 Transcribing our calls would cost us quite a bit so we are not looking at that at this time.
58. 1:17:07 With leronlimab what we have seen is [in the Covid19] critically ill patient population, no other compound has shown that kind of result.
59. 1:18:31 30-40% of all the cases of Covid19 will probably have some degree of longhauler symptoms.
60. 1:19:10 management team, history
61. 1:23:33 sepsis
62. 1:24:48 Covid19, HIV, Cancer
63. 1:26:00 production- Samsung is still comfortable with us and has assured us they will make any amount of product we want. We feel strong about Samsung.
64. 1:27:10 We are in discussions with people are considering paying for trials where we only supply leronlimab and a few other things in multiple countries. We are very excited about that and think that it is a sign that people are believing in our drug and it’s safety.
65. 1:28:10 Patients could perhaps transfer to a hospital with a trial even if they are from another state and might be enrolled if they qualify with the inclusion criteria of the trial.
66. 1:29:44 vials- Samsung could produce millions of vials a month. Right now we have about 500,000 vials, bulk product for 600,000 vials, and some from the past. The total number comes to about 1.3 million vials that we could have available if we are trying to sell.
67. 1:31:10 Operation Warp Speed- I believe, but can’t confirm 100%, that all the possibilities are there as long as we get an EUA. We have talked with them before and that is what they indicated.
68. 1:31:50 CD16 is our focus to get approval for Covid19. We have green light from FDA to go forward, but made a change and sent to the FDA this morning (March 22) and await their response.
69. 1:32:39 Longhaulers- We are so close to getting answers. I’m very very excited and I hope shareholders are sharing in the excitement.
SOME RELATED LINKS
• March 22, 2021 conference call link to listen
https://www.cytodyn.com/investors/news-events...ty-webcast
• March 8, 2021 SEC 8K with executive summary & graphs of CD12 trial data Covid19 critical cases 2021.03.08
https://www.sec.gov/Archives/edgar/data/11756...dex991.htm
• March 8, 2021 conference call notes (Not a transcript)
https://investorshangout.com/post/view?id=6080669
(36)
(0)CytoDyn Inc (CYDY) Stock Research Links
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