more thoughts from The oNiOnHEAd
Here are some more notes - some paraphrased, and some quotes, without the marks, not very detailed - there are surely some errors. Most of the following deals with the Q&A session.
There will be a press release covering the study endpoints. Nader says they want to get all the efficacy data. All physicians involved in the study will contributors to a paper published in a major journal.
A. Interim analysis of 50 patients?
Nader - when he said 50, he was hoping they would do 50, but "slapped around by our regulatory team more than I can count." (more on this that I didn't get - something about a higher number)
Question regarding MS:
Nader - Trying hard to get an MS study going. A mountain of people fighting the company.
Question: Why did a drug like Remdesivir get approved by FDA, but leronlimab, not?
Nader: I wake up every morning very early, very anxious... my team has been spectacular... I have to say when you have 2000 drug companies saying that they got their miracle drug...(apparent there are too many companies wanting the FDA's attention)... We are trying so hard to get the results to the FDA. You just heard fantastic results... I have to defend FDA in this... They relaxed CD12 for us, twice...
Questioner doesn't give up, asks a follow up question, can Cytodyn approach the President.
Nader, FDA has not shorted us. They immediately waived the waiting time, FDA has not given these considerations to anyone else.
FDA has NOT seen any of the results. Mexico changed direction and wanted to do combo therapy, we are not into that.
Q. With all wonderful results, what is plan for federal funding?
A. Nader - Told the team not to work on that because it takes so much resources. When we hear from FDA that we have approval, all those doors will open - we've chosen this different path.
Q. Do you have a real good contact to converse with at FDA. If so, do you share results?
A. Nader - the way FDA works is very solid, with clear rules and regulations. Our contact person is a lady who communicates with Amerex, X-CEO who formerly worked with/for FDA. Everything is much more solid (formal).
Q. How rapidly did patients in CD10 clear the virus compared to control group?
A. Nader - the score that was used to determine endpoint, Day 3, and secondary endpoint. Everyone must wait until we have regulatory support to see the topline results.
Q. Any studies being done for children with lymphoma.
A. Dr. We've screened several... but no efficacy results are available. Nader - we haven't done any pediatric studies.
Q. Are separate patents required for separate indications?
A. Dr. Kelly - working with legal team for that?
Nader - Composition material Patent gives us the right to not have anybody use the product for any other indication.
We have exclusive right of 12 years because patent is for biologic.
Q1. Regeneron change primary endpoint. Can Cytodyn do that in the context of having such fabulous SAE numbers - is a consideration?
Nader - We didn't do phase 3, we did phase 2 (proof of concept). When you have a phase 2 and strong results, if indication is unmet medical need, you can get breakthrough designation, which Cytodyne believes Covid-19 qualifies. Secondary endpoint is as important as primary endpoint
Dr. Kelly - no reason to change endpoint, now, many people are using SAE as endpoint.
Q2. Number of vials dropping - opportunity for production that we don't know about. 600 - 700 vials expected
Nader - Samsung got booked, couldn't make what Cytodyne wanted. Samsung CEO very close to me (Nader), did the 1 million et al vials even though they were booked. 2021 - Samsung will do their best. Another facility, AGC will also be working on it - maybe 100k vials but trying to get more, Nader will let everyone know. With FDA approval, funding not a problem (ie. to get more production).
Q1. Question for doctors
Does this decrease or eliminate viral load by Day 14?
Q2. If there WAS a phase 3 trial, what would it look like, how long would it take? Nader not about to eleborate?
Q3. Cytokine Storm related to influenza?
Q4. Can decrease tumor necrosis factor?
Dr. ? - leronlimab restores CD8, which affects viral load. Exploring cytokine storm related to influenza
Q. Regarding 28 million - are there conditions to financing related to the current trials.
? - no milestones tied to funding, closed yesterday, expected today.
Q. Heard about positive results, but did not talk about the magnitude.
A. Nader - Magnitude will be in topline report.
We have very positive results in Day 3, 7 and 14.
Believe it will be better than Remdesivir. Let's see what the FDA will say.
Q1. Heard or seen Trump mentioned he's looking forward to a therapeutic (shot). Any idea of referring to leronlimab?
Nader - I have no idea. Scott, are we the only ones? Scott - most are IV infusions. We are the only one's with SubQ injections.
Q2. Several weeks ago - mentioned papers out there with positive peer review.
Nader 3 papers now (names), hoping to be out next week. No idea why taking so long.
Final Q. Wants to elab on earlier question. PR on primary and secondary endpoints going to be released?
Nader - next week we report on CD12 safety. CD10 top line report hope to be released in 10 days. Most doctors and patients in that paper.
Nader - no one dares go after (other bio-pharmas attempt to treat certain class of patients) (implying only Cytodyn does)
CD12 is trial based on 60 major INDs, very happy to announce those results. Cancer trial is going forward. Going to have a meeting with FDA - will ask for guidance on monotherapy and combo therapy.
Someone just paid us $10 per share. We just bought ourselves a lot of time and a lot of money. We don't choose to merely go on, but want shareholders to get fruits of hard work.
Here are some more notes - some paraphrased, and some quotes, without the marks, not very detailed - there are surely some errors. Most of the following deals with the Q&A session.
There will be a press release covering the study endpoints. Nader says they want to get all the efficacy data. All physicians involved in the study will contributors to a paper published in a major journal.
A. Interim analysis of 50 patients?
Nader - when he said 50, he was hoping they would do 50, but "slapped around by our regulatory team more than I can count." (more on this that I didn't get - something about a higher number)
Question regarding MS:
Nader - Trying hard to get an MS study going. A mountain of people fighting the company.
Question: Why did a drug like Remdesivir get approved by FDA, but leronlimab, not?
Nader: I wake up every morning very early, very anxious... my team has been spectacular... I have to say when you have 2000 drug companies saying that they got their miracle drug...(apparent there are too many companies wanting the FDA's attention)... We are trying so hard to get the results to the FDA. You just heard fantastic results... I have to defend FDA in this... They relaxed CD12 for us, twice...
Questioner doesn't give up, asks a follow up question, can Cytodyn approach the President.
Nader, FDA has not shorted us. They immediately waived the waiting time, FDA has not given these considerations to anyone else.
FDA has NOT seen any of the results. Mexico changed direction and wanted to do combo therapy, we are not into that.
Q. With all wonderful results, what is plan for federal funding?
A. Nader - Told the team not to work on that because it takes so much resources. When we hear from FDA that we have approval, all those doors will open - we've chosen this different path.
Q. Do you have a real good contact to converse with at FDA. If so, do you share results?
A. Nader - the way FDA works is very solid, with clear rules and regulations. Our contact person is a lady who communicates with Amerex, X-CEO who formerly worked with/for FDA. Everything is much more solid (formal).
Q. How rapidly did patients in CD10 clear the virus compared to control group?
A. Nader - the score that was used to determine endpoint, Day 3, and secondary endpoint. Everyone must wait until we have regulatory support to see the topline results.
Q. Any studies being done for children with lymphoma.
A. Dr. We've screened several... but no efficacy results are available. Nader - we haven't done any pediatric studies.
Q. Are separate patents required for separate indications?
A. Dr. Kelly - working with legal team for that?
Nader - Composition material Patent gives us the right to not have anybody use the product for any other indication.
We have exclusive right of 12 years because patent is for biologic.
Q1. Regeneron change primary endpoint. Can Cytodyn do that in the context of having such fabulous SAE numbers - is a consideration?
Nader - We didn't do phase 3, we did phase 2 (proof of concept). When you have a phase 2 and strong results, if indication is unmet medical need, you can get breakthrough designation, which Cytodyne believes Covid-19 qualifies. Secondary endpoint is as important as primary endpoint
Dr. Kelly - no reason to change endpoint, now, many people are using SAE as endpoint.
Q2. Number of vials dropping - opportunity for production that we don't know about. 600 - 700 vials expected
Nader - Samsung got booked, couldn't make what Cytodyne wanted. Samsung CEO very close to me (Nader), did the 1 million et al vials even though they were booked. 2021 - Samsung will do their best. Another facility, AGC will also be working on it - maybe 100k vials but trying to get more, Nader will let everyone know. With FDA approval, funding not a problem (ie. to get more production).
Q1. Question for doctors
Does this decrease or eliminate viral load by Day 14?
Q2. If there WAS a phase 3 trial, what would it look like, how long would it take? Nader not about to eleborate?
Q3. Cytokine Storm related to influenza?
Q4. Can decrease tumor necrosis factor?
Dr. ? - leronlimab restores CD8, which affects viral load. Exploring cytokine storm related to influenza
Q. Regarding 28 million - are there conditions to financing related to the current trials.
? - no milestones tied to funding, closed yesterday, expected today.
Q. Heard about positive results, but did not talk about the magnitude.
A. Nader - Magnitude will be in topline report.
We have very positive results in Day 3, 7 and 14.
Believe it will be better than Remdesivir. Let's see what the FDA will say.
Q1. Heard or seen Trump mentioned he's looking forward to a therapeutic (shot). Any idea of referring to leronlimab?
Nader - I have no idea. Scott, are we the only ones? Scott - most are IV infusions. We are the only one's with SubQ injections.
Q2. Several weeks ago - mentioned papers out there with positive peer review.
Nader 3 papers now (names), hoping to be out next week. No idea why taking so long.
Final Q. Wants to elab on earlier question. PR on primary and secondary endpoints going to be released?
Nader - next week we report on CD12 safety. CD10 top line report hope to be released in 10 days. Most doctors and patients in that paper.
Nader - no one dares go after (other bio-pharmas attempt to treat certain class of patients) (implying only Cytodyn does)
CD12 is trial based on 60 major INDs, very happy to announce those results. Cancer trial is going forward. Going to have a meeting with FDA - will ask for guidance on monotherapy and combo therapy.
Someone just paid us $10 per share. We just bought ourselves a lot of time and a lot of money. We don't choose to merely go on, but want shareholders to get fruits of hard work.
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