This was posted on another board:
I. CEO said that 3 papers are being printed about anecdotal (pre-trial)
(A) Dr. Harish Seethamraju - 11 patients
(
Dr. Otto Yang - 29 patients
(C) Dr. Nicholas Agresti - 4 patients (agresti)
II. Shorting (Andrew Left, Citron)
- FINRA/SEC probably will be looking into it
- 51 million shares trading
III. Story of how it got started at COVID
- CYDY heard that CCR-5 was related to COVID, so asked for Phase II from FDA. But FDA said no because no data from lab or animals on COVID.
- But then Dr. Seethamraju applied
IV. Un-blinding
- 86 patients in mild/moderate June 17 - patient enrolled. July 1 done (14 days).
- Cannot unblind immediately. Need every hospital to sign that their data is correct, etc.
- We will have results in July, don't know how quickly. Hesitant to say projection
V. Uplisting
NASDAQ
- have price to qualify
- have potential to raise money for NASDAQ
- does not want to raise money and dilute
- double digits is not enough
- every banker told me i'm stupid
- We're going to uplist on NASDAQ but try to avoid raising money
- Should have something to talk about within a few weeks
VI. Mike Mulholland up his sleeve
- shortcut to uplisting (of allowing to join NASDAQ without funding requirement)
- waiting to hear back if they will allow
VII. Talking with Big Pharma
- Every license/buyout discussion requires CDA (confidentiality agreement)
- We have been talking to Big Pharma & Big Media
- Will hear when results come out
- Will be multiple opportunities
VIII. Trials
- Capacity: 1.2 million vials this year and 10 million vials next year
- But if we have what we think we have, and we get approval, we'll have all the help we need from the government and other funding situations that are not dilutive.
VIII. Foreign Countries
- Our CRO (?) Amorex is very efficient
- United Kingdom: Took a while for them to get clearance, but trial should start soon.
- Mexico: we are very responsive--took 2 weeks for country to get memorandum of understanding. CYDY got back to them within a couple of days
- Brazil: also starting at some point soon, but they are dragging a bit.
IX. Q. Why is it taking so long for Leronlimab to get traction (vs. Remdesevir)
- Only Dr. Seethamraju requested it for EIND.
- Also, CCR-5 is a relatively new focus of study
- Initially, FDA didn't think it was promising
- But Gilead and Remdesevir were known, so FDA supported and got 50 sites up and running
- But as time passed, FDA came on board.
X. India and Pakistan?
- They have not reached out.
- CYDY doesn't reach out to countries but our hands are full; but we are very responsive to requests.
- So countries need to have their own health departments contact CYDY (here's my email)
- Interviewer offers to connect CYDY with these countries
XI. Pricing
- We will match/beat Remdesevir
- There are wealthy people who want to fund production for other countries, and we are happy to work with them and make a bit less in other countries.
XII. Contra-indications
- Have found zero drug-drug interactions
- Dr. Paul Madden (inventor) --> couldn't even kill a rat with it if we tried.
- Helps tremendously with MS (?)
- Animal studies with NASH have been amazing
XIII. Approval?
- How possible/likely is approval straight after Phase II?
- The issue is if there is "unmet medical need" can get quicker approval.
- Don't know what FDA will say..
XIV. Uninsured patients?
- Can they get the drug?
- presumably hospitals will give it out,
XV. Other uses of Leronlimab
- Dr. Lalezari (senior) has been at Einstein for 60 years
* wants to do trial immediately at Montefiore for Alzheimers
- NASH trial -- get started
- GBHT (?) - going on
- Cancer -- 23 difference cancers
- MS --> told Amorex to go forward
- HIV ongoing
- 10 trials this year (4 already in process, 6 more to go)
XVI. Dr. Patterson's Research
- The data from those labs belongs to Cydy
- But we like to let the doctors publish on their own ( Seethamraju, Yang, Agresti)
- Patterson has been great
- We've been getting leaders in each field
- Q: Patterson's paper? A: Labwork from IncellDX (?) re: CD-10, CD-12 (?)
XVII. Severe/Critical Trial Update
- Sitting at 127 patients, so no interim on 51 patients
- Being careful not to make any mistakes
- Hope to have data of CD-10 and CD-12 at same time
XVIII. Breast Cancer patients?
- 13 patients have (tumor?) at 0
- basket trial (?)
XIX. Comment -- So much appreciation for your work and your wife's contribution to the company.
XX. Surprise Question: What is the secret of leadership (one or two things) that you have learned and would like to share?
- I like to learn myself
- When I look at project and entrepreneur, must look at things in two ways: (a) analyze situation, get acquainted with every variable (monother
I. CEO said that 3 papers are being printed about anecdotal (pre-trial)
(A) Dr. Harish Seethamraju - 11 patients
(
Dr. Otto Yang - 29 patients (C) Dr. Nicholas Agresti - 4 patients (agresti)
II. Shorting (Andrew Left, Citron)
- FINRA/SEC probably will be looking into it
- 51 million shares trading
III. Story of how it got started at COVID
- CYDY heard that CCR-5 was related to COVID, so asked for Phase II from FDA. But FDA said no because no data from lab or animals on COVID.
- But then Dr. Seethamraju applied
IV. Un-blinding
- 86 patients in mild/moderate June 17 - patient enrolled. July 1 done (14 days).
- Cannot unblind immediately. Need every hospital to sign that their data is correct, etc.
- We will have results in July, don't know how quickly. Hesitant to say projection
V. Uplisting
NASDAQ
- have price to qualify
- have potential to raise money for NASDAQ
- does not want to raise money and dilute
- double digits is not enough
- every banker told me i'm stupid
- We're going to uplist on NASDAQ but try to avoid raising money
- Should have something to talk about within a few weeks
VI. Mike Mulholland up his sleeve
- shortcut to uplisting (of allowing to join NASDAQ without funding requirement)
- waiting to hear back if they will allow
VII. Talking with Big Pharma
- Every license/buyout discussion requires CDA (confidentiality agreement)
- We have been talking to Big Pharma & Big Media
- Will hear when results come out
- Will be multiple opportunities
VIII. Trials
- Capacity: 1.2 million vials this year and 10 million vials next year
- But if we have what we think we have, and we get approval, we'll have all the help we need from the government and other funding situations that are not dilutive.
VIII. Foreign Countries
- Our CRO (?) Amorex is very efficient
- United Kingdom: Took a while for them to get clearance, but trial should start soon.
- Mexico: we are very responsive--took 2 weeks for country to get memorandum of understanding. CYDY got back to them within a couple of days
- Brazil: also starting at some point soon, but they are dragging a bit.
IX. Q. Why is it taking so long for Leronlimab to get traction (vs. Remdesevir)
- Only Dr. Seethamraju requested it for EIND.
- Also, CCR-5 is a relatively new focus of study
- Initially, FDA didn't think it was promising
- But Gilead and Remdesevir were known, so FDA supported and got 50 sites up and running
- But as time passed, FDA came on board.
X. India and Pakistan?
- They have not reached out.
- CYDY doesn't reach out to countries but our hands are full; but we are very responsive to requests.
- So countries need to have their own health departments contact CYDY (here's my email)
- Interviewer offers to connect CYDY with these countries
XI. Pricing
- We will match/beat Remdesevir
- There are wealthy people who want to fund production for other countries, and we are happy to work with them and make a bit less in other countries.
XII. Contra-indications
- Have found zero drug-drug interactions
- Dr. Paul Madden (inventor) --> couldn't even kill a rat with it if we tried.
- Helps tremendously with MS (?)
- Animal studies with NASH have been amazing
XIII. Approval?
- How possible/likely is approval straight after Phase II?
- The issue is if there is "unmet medical need" can get quicker approval.
- Don't know what FDA will say..
XIV. Uninsured patients?
- Can they get the drug?
- presumably hospitals will give it out,
XV. Other uses of Leronlimab
- Dr. Lalezari (senior) has been at Einstein for 60 years
* wants to do trial immediately at Montefiore for Alzheimers
- NASH trial -- get started
- GBHT (?) - going on
- Cancer -- 23 difference cancers
- MS --> told Amorex to go forward
- HIV ongoing
- 10 trials this year (4 already in process, 6 more to go)
XVI. Dr. Patterson's Research
- The data from those labs belongs to Cydy
- But we like to let the doctors publish on their own ( Seethamraju, Yang, Agresti)
- Patterson has been great
- We've been getting leaders in each field
- Q: Patterson's paper? A: Labwork from IncellDX (?) re: CD-10, CD-12 (?)
XVII. Severe/Critical Trial Update
- Sitting at 127 patients, so no interim on 51 patients
- Being careful not to make any mistakes
- Hope to have data of CD-10 and CD-12 at same time
XVIII. Breast Cancer patients?
- 13 patients have (tumor?) at 0
- basket trial (?)
XIX. Comment -- So much appreciation for your work and your wife's contribution to the company.
XX. Surprise Question: What is the secret of leadership (one or two things) that you have learned and would like to share?
- I like to learn myself
- When I look at project and entrepreneur, must look at things in two ways: (a) analyze situation, get acquainted with every variable (monother
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