Updated after 9-2-2020 Conference Call
Potential Catalysts w/ Est. Dates 9-3-2020
COVID CD10 Mild / Moderate
- UK MHRA Delivery of Data Package – September 4
- UK MHRA Pre-BLA Fast Track Meeting – September 9
- UK MHRA Ruling – ?
- US FDA EUA Ruling – “Forthcoming”
- Mexico NIH Ruling – ?
- EU EMA Submission – ?
- Philippines FDA Submission – ?
- Israel MOH Submission – ?
* The US FDA may grant Phase 4 Confirmational or demand a Phase 3 Registrational
COVID CD12 Severe / Critical
- US FDA Interim 28-Day Completion – Sept 23
- US FDA Interim Top-Line Results – First Half Oct
- US FDA Interim EUA Submission – Oct
- US FDA Interim EUA Ruling – ?
- UK MHRA Interim EUA Submission – Oct
- UK MHRA Interim EUA Ruling – ?
* The US FDA may demand full Phase 3 enrollment (390)
COVID Funding / Partnerships
- UK MHRA UPH Urgent Public Health Submission – Sept/Oct
- US OWS / Funding / Grants Update – Sept/Oct
- Worldwide Pharma License/Partnership Update – Sept/Oct
- Small Pharma License/Partnership Update: Asia, Brazil, China, India, Europe, Middle East, Northern Africa – Sept/Oct
COVID Manuscripts
- Dr. Patterson Peer Reviewed Paper – Very Soon
- CD10 Paper Dr. Seethamraju Review – Week of Sept 7
- CD10 Paper Dr. Seethamraju Submit – ?
- CD10 Abstract Results Submit – ?
- Dr. Yang Paper - 29-Patients – Submitted
- Dr. Yang Paper Publish – ?
- Dr. Agresti Paper - 4-Patients – Submitted
- Dr. Agresti Paper Publish – ?
COVID Miscellaneous Items
- Samsung Biologics Shipment Update – Sept/Oct
- Mainstream Media Update – Sept/Oct
- IncellDx Companion Assay Kits – Sept/Oct
- Brazil ANVISA COVID Trial Update – ?
HIV Indications
- US FDA Combo HIV BLA Type A Meeting (w/Mono Guidance) – Sept 8
- US FDA Combo HIV BLA Multidisciplinary Review – 30+ Days
- US FDA Combo HIV BLA Re-Submission (w/Mono?) – ?
- US FDA Combo HIV (w/Mono?) Ruling– ?
- UK MHRA Combo & Mono Pre-BLA Meeting – By Sept 20
- UK MHRA Combo & Mono BLA Submission – ?
- UK MHRA Combo & Mono BLA Ruling – ?
- US HIV Cure Trial Update – ?
- US HIV PrEP OHSU/Sacha Animal Study Completion – Aug 2025
HIV Manuscripts
- HIV PrEP Animal Study Paper – Sept
- CD01 Extension Paper – Sept
- CD02 & CD03 Papers – ?
Cancer Indications
- US FDA Response to Basket 700mg Change – ?
- US FDA BTD Cancer Meeting: mTNBC + Basket 22 – Sept
- US mTNBC Trial Update – ?
- US Cancer Basket 22 Trial Update – ?
- Taiwan Cancer Basket Trial Update – ?
Other Indications
- MS Trial Update – ?
- NASH Trial Update – 1st Patient Sept
- GvHD Trial Update – ?
- Alzheimer’s Trial Update – ?
Corporate Items
- Science Advisory Board Update PR – Sept
- Investment Bank Update – Sept/Oct
- NASDAQ Uplist Est. Date – Sept/Oct
- Next Capital Raise Post Approval or Uplist – ?
Potential Additional Trials for 2020:
As reported from time-to-time by CYDY
Phase 2:
- Influenza
- Stroke
- Septic Shock
- IBS Inflammatory Bowel Syndrome
- Psoriasis
- Autoimmune Hepatitis
Phase 3:
- US COVID PrEP
- US COVID Long Hauler (Label Expansion?)
- HIV Mono Therapy
Completed Catalysts
- Dr.BP Paper Pre-print
- US COVID Pediatric Protocol
- NEJM Submissions Amarex Montefiore / Georgia
- US COVID Distribution Agreement
- Dr. Sacha HIV PrEP Presentation
- Small Capital Raise Before Uplist
- US COVID P2 M/M Top Line Efficacy Results
- US COVID P2 M/M FDA EUA Unmet Need Submission – Aug 12
- SEC 10k & Audited Financials Complete – Aug 17
- Mexico NIH P2 M/M Submission – Aug 17
- UK MHRA P2 M/M “Fast Track” Submit – Aug 19
- UK MHRA Enrollment
- US FDA Interim Enrollment (195) – Aug 25
Back-Burner Catalysts
- Dr.BP Paper #2 Pre-Print
- Dr.BP Paper #2 Peer Review
- Dr.BP Infectious Virus in Plasma
- Dr.BP Rantes Susceptibility Testing Program
- Commercialization Officer Full-Time Hire
Rejected Catalysts
- US COVID Emergency eIND
- US COVID Compassionate Use Pre-July
- Mexico NIH COVID Combo Trial
- US COVID P3 3-Arm Trial w/ Remdesivir
Potential Catalysts w/ Est. Dates 9-3-2020
COVID CD10 Mild / Moderate
- UK MHRA Delivery of Data Package – September 4
- UK MHRA Pre-BLA Fast Track Meeting – September 9
- UK MHRA Ruling – ?
- US FDA EUA Ruling – “Forthcoming”
- Mexico NIH Ruling – ?
- EU EMA Submission – ?
- Philippines FDA Submission – ?
- Israel MOH Submission – ?
* The US FDA may grant Phase 4 Confirmational or demand a Phase 3 Registrational
COVID CD12 Severe / Critical
- US FDA Interim 28-Day Completion – Sept 23
- US FDA Interim Top-Line Results – First Half Oct
- US FDA Interim EUA Submission – Oct
- US FDA Interim EUA Ruling – ?
- UK MHRA Interim EUA Submission – Oct
- UK MHRA Interim EUA Ruling – ?
* The US FDA may demand full Phase 3 enrollment (390)
COVID Funding / Partnerships
- UK MHRA UPH Urgent Public Health Submission – Sept/Oct
- US OWS / Funding / Grants Update – Sept/Oct
- Worldwide Pharma License/Partnership Update – Sept/Oct
- Small Pharma License/Partnership Update: Asia, Brazil, China, India, Europe, Middle East, Northern Africa – Sept/Oct
COVID Manuscripts
- Dr. Patterson Peer Reviewed Paper – Very Soon
- CD10 Paper Dr. Seethamraju Review – Week of Sept 7
- CD10 Paper Dr. Seethamraju Submit – ?
- CD10 Abstract Results Submit – ?
- Dr. Yang Paper - 29-Patients – Submitted
- Dr. Yang Paper Publish – ?
- Dr. Agresti Paper - 4-Patients – Submitted
- Dr. Agresti Paper Publish – ?
COVID Miscellaneous Items
- Samsung Biologics Shipment Update – Sept/Oct
- Mainstream Media Update – Sept/Oct
- IncellDx Companion Assay Kits – Sept/Oct
- Brazil ANVISA COVID Trial Update – ?
HIV Indications
- US FDA Combo HIV BLA Type A Meeting (w/Mono Guidance) – Sept 8
- US FDA Combo HIV BLA Multidisciplinary Review – 30+ Days
- US FDA Combo HIV BLA Re-Submission (w/Mono?) – ?
- US FDA Combo HIV (w/Mono?) Ruling– ?
- UK MHRA Combo & Mono Pre-BLA Meeting – By Sept 20
- UK MHRA Combo & Mono BLA Submission – ?
- UK MHRA Combo & Mono BLA Ruling – ?
- US HIV Cure Trial Update – ?
- US HIV PrEP OHSU/Sacha Animal Study Completion – Aug 2025
HIV Manuscripts
- HIV PrEP Animal Study Paper – Sept
- CD01 Extension Paper – Sept
- CD02 & CD03 Papers – ?
Cancer Indications
- US FDA Response to Basket 700mg Change – ?
- US FDA BTD Cancer Meeting: mTNBC + Basket 22 – Sept
- US mTNBC Trial Update – ?
- US Cancer Basket 22 Trial Update – ?
- Taiwan Cancer Basket Trial Update – ?
Other Indications
- MS Trial Update – ?
- NASH Trial Update – 1st Patient Sept
- GvHD Trial Update – ?
- Alzheimer’s Trial Update – ?
Corporate Items
- Science Advisory Board Update PR – Sept
- Investment Bank Update – Sept/Oct
- NASDAQ Uplist Est. Date – Sept/Oct
- Next Capital Raise Post Approval or Uplist – ?
Potential Additional Trials for 2020:
As reported from time-to-time by CYDY
Phase 2:
- Influenza
- Stroke
- Septic Shock
- IBS Inflammatory Bowel Syndrome
- Psoriasis
- Autoimmune Hepatitis
Phase 3:
- US COVID PrEP
- US COVID Long Hauler (Label Expansion?)
- HIV Mono Therapy
Completed Catalysts
- Dr.BP Paper Pre-print
- US COVID Pediatric Protocol
- NEJM Submissions Amarex Montefiore / Georgia
- US COVID Distribution Agreement
- Dr. Sacha HIV PrEP Presentation
- Small Capital Raise Before Uplist
- US COVID P2 M/M Top Line Efficacy Results
- US COVID P2 M/M FDA EUA Unmet Need Submission – Aug 12
- SEC 10k & Audited Financials Complete – Aug 17
- Mexico NIH P2 M/M Submission – Aug 17
- UK MHRA P2 M/M “Fast Track” Submit – Aug 19
- UK MHRA Enrollment
- US FDA Interim Enrollment (195) – Aug 25
Back-Burner Catalysts
- Dr.BP Paper #2 Pre-Print
- Dr.BP Paper #2 Peer Review
- Dr.BP Infectious Virus in Plasma
- Dr.BP Rantes Susceptibility Testing Program
- Commercialization Officer Full-Time Hire
Rejected Catalysts
- US COVID Emergency eIND
- US COVID Compassionate Use Pre-July
- Mexico NIH COVID Combo Trial
- US COVID P3 3-Arm Trial w/ Remdesivir
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