Potential Catalysts w/ Est. Dates 10-24-2020
COVID P2 – CD10 Mild / Moderate
- Philippines FDA EUA Submission – ?
COVID P3 CD12 Severe / Critical
- US FDA Interim 293 Enrollment – ?
- US FDA Interim 293 Completion – Enrollment +42 Days
- US FDA Interim 293 Readout – Enrollment +63 Days
- US FDA Interim EUA Submission – ?
- US FDA Interim EUA Ruling – ?
- US OWS / Funding / Grants Update – ?
- UK MHRA Enrollment Update 4 Sites – ?
- UK MHRA UPH Urgent Public Health Submission Update – ?
- UK MHRA Interim EUA Submission – ?
- UK MHRA Interim EUA Ruling – ?
- UK MHRA PIM (=BTD: Promising Innovative Medicine) Ruling – ?
- UK MHRA EAMS (Early Access to Medicines Scheme) – ?
- UK MHRA Clinical Trial Enrollment Update (5-10 sites) – ?
- Philippines FDA EUA Submission – ?
- EU EMA – ?
- Mexico NIH – ?
- Israel MOH – ?
- Canada HPFB – ?
* The US FDA may demand full Phase 3 enrollment (390)
COVID P3 - CDxx Moderate
- US FDA Protocol Submission – On Hold ?
- US FDA Enrollment – ?
COVID P2 CDxx Long Hauler
- US FDA Protocol Acceptance (~70 Patients) – ?
- US FDA Enrollment – ?
COVID Funding / Partnerships
- 11-Big Pharma License / Partnership Update – ?
- Small Pharma License / Partnership Update: Asia, Brazil, China, India, Europe, Middle East, Northern Africa – ?
COVID Manuscripts
- eIND – 11-Patients Dr. Bruce Patterson
- eIND – 11-Patients Dr. Harish Seethamraju
- eIND – 30-Patients Dr. Otto Yang
- eIND – 5-Patients Dr. Nicholas Agresti
- CD10 – Phase 2, Lead Author is Dr. Seethamraju (not submitted yet)
COVID Miscellaneous Items
- Samsung Biologics Shipment (50k + 300k + 900k) Update – ?
- Mainstream Media Update – ?
- IncellDx Companion Assay Kits – ?
- Brazil ANVISA COVID Trial Update – ?
HIV Indications
- US FDA P3 Combo BLA Receptor Occupancy Response – ?
- US FDA P3 Combo BLA Multidisciplinary Review – ?
- US FDA P3 Combo BLA Submission – ?
- US FDA P3 Combo Priority Review Update – ?
- US FDA P3 Combo Ruling– ?
- US FDA P3 Mono Protocol Update – ?
- UK MHRA P3 Combo (Mono?) Pre-BLA Meeting – Oct 26
- UK MHRA P3 Combo (Mono?) BLA Submission – ?
- UK MHRA P3 Combo (Mono?) BLA Ruling – ?
- EU EMA Combo (Mono?) Pre-BLA Meeting – ?
- EU EMA Combo (Mono?) BLA Submission – ?
- EU EMA Combo (Mono?) BLA Ruling – ?
- Canada HPFB P3 Combo (Mono?) Pre-BLA Meeting – Nov 9
- Canada HPFB P3 Combo (Mono?) BLA Submission – ?
- Canada HPFB P3 Combo (Mono?) BLA Ruling – ?
- US FDA P2 HIV Cure Trial Update – 2020-2021 ?
- US FDA P2 PrEP Trial Update – 2021 ?
- Mexico NIH – ?
- Israel MOH – ?
HIV Manuscripts
- CD01 P2 Ext-Monotherapy (5 patients 6 years) Dr. Sacha
- Cure Animal study Dr. Jonah Sacha
- CD02 P3 With primary endpoint achieved
- CD03 Phase 3 Ext-Mono (~215 - 1 year, 40 2-4 years)
- PrEP – Animal study Dr. Jonah Sacha
Cancer Indications
- US FDA Response to Basket 700mg Change – ?
- Creative Microtechnology Analysis of Basket Trial for BTD – ?
- US P2 mTNBC Trial Update – ?
- US P2 Cancer Basket 22 Trial Update – ?
- US FDA BTD Ruling mTNBC – ?
- US FDA BTD Ruling Basket 22 – ?
- Taiwan Cancer Basket Trial Update – ?
Other Active Indications
- US P2 GvHD Trial Update (Goal: 5 Patients) – ?
- US P2 NASH Trial Update – 1st Patient Nov ?
- US P2 MS Trial Update – ?
- US P2 Stroke Update – ?
- US Alzheimer’s Trial Update – ?
Corporate Items
- Science Advisory Board Update PR – ?
- Investment Bank Update – ?
- NASDAQ Uplist Update – ?
- Next Capital Raise – ?
- Right to Try Act (State-based) Update – ?
Potential Additional Trials:
As reported from time-to-time by CYDY
Phase 2:
- Influenza
- Seizures
- Septic Shock
- Traumatic Brain Injury
- Various Autoimmune Diseases
- IBS Inflammatory Bowel Syndrome
- Psoriasis
- Autoimmune Hepatitis
- US HIV P2 Cure – (see above) 2020-2021
- US HIV P2 PrEP – (see above) 2021
Phase 3:
- HIV Mono Therapy (see above) 2020
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
- UK MHRA Delivery of Data Package – Sept 4
- US FDA Interim 28-Day Completion – Sept 23
- US FDA Combo HIV BLA Type A Meeting – Sept 8
- UK MHRA Pre-BLA Fast Track Meeting – Sept 9
- Philippines Distribution Agreement – Oct 13
- US FDA Interim 195 Readout – Oct 20
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
- Mexico COVID P3 3-Arm Trial w/ Remdesivir
COVID P2 – CD10 Mild / Moderate
- Philippines FDA EUA Submission – ?
COVID P3 CD12 Severe / Critical
- US FDA Interim 293 Enrollment – ?
- US FDA Interim 293 Completion – Enrollment +42 Days
- US FDA Interim 293 Readout – Enrollment +63 Days
- US FDA Interim EUA Submission – ?
- US FDA Interim EUA Ruling – ?
- US OWS / Funding / Grants Update – ?
- UK MHRA Enrollment Update 4 Sites – ?
- UK MHRA UPH Urgent Public Health Submission Update – ?
- UK MHRA Interim EUA Submission – ?
- UK MHRA Interim EUA Ruling – ?
- UK MHRA PIM (=BTD: Promising Innovative Medicine) Ruling – ?
- UK MHRA EAMS (Early Access to Medicines Scheme) – ?
- UK MHRA Clinical Trial Enrollment Update (5-10 sites) – ?
- Philippines FDA EUA Submission – ?
- EU EMA – ?
- Mexico NIH – ?
- Israel MOH – ?
- Canada HPFB – ?
* The US FDA may demand full Phase 3 enrollment (390)
COVID P3 - CDxx Moderate
- US FDA Protocol Submission – On Hold ?
- US FDA Enrollment – ?
COVID P2 CDxx Long Hauler
- US FDA Protocol Acceptance (~70 Patients) – ?
- US FDA Enrollment – ?
COVID Funding / Partnerships
- 11-Big Pharma License / Partnership Update – ?
- Small Pharma License / Partnership Update: Asia, Brazil, China, India, Europe, Middle East, Northern Africa – ?
COVID Manuscripts
- eIND – 11-Patients Dr. Bruce Patterson
- eIND – 11-Patients Dr. Harish Seethamraju
- eIND – 30-Patients Dr. Otto Yang
- eIND – 5-Patients Dr. Nicholas Agresti
- CD10 – Phase 2, Lead Author is Dr. Seethamraju (not submitted yet)
COVID Miscellaneous Items
- Samsung Biologics Shipment (50k + 300k + 900k) Update – ?
- Mainstream Media Update – ?
- IncellDx Companion Assay Kits – ?
- Brazil ANVISA COVID Trial Update – ?
HIV Indications
- US FDA P3 Combo BLA Receptor Occupancy Response – ?
- US FDA P3 Combo BLA Multidisciplinary Review – ?
- US FDA P3 Combo BLA Submission – ?
- US FDA P3 Combo Priority Review Update – ?
- US FDA P3 Combo Ruling– ?
- US FDA P3 Mono Protocol Update – ?
- UK MHRA P3 Combo (Mono?) Pre-BLA Meeting – Oct 26
- UK MHRA P3 Combo (Mono?) BLA Submission – ?
- UK MHRA P3 Combo (Mono?) BLA Ruling – ?
- EU EMA Combo (Mono?) Pre-BLA Meeting – ?
- EU EMA Combo (Mono?) BLA Submission – ?
- EU EMA Combo (Mono?) BLA Ruling – ?
- Canada HPFB P3 Combo (Mono?) Pre-BLA Meeting – Nov 9
- Canada HPFB P3 Combo (Mono?) BLA Submission – ?
- Canada HPFB P3 Combo (Mono?) BLA Ruling – ?
- US FDA P2 HIV Cure Trial Update – 2020-2021 ?
- US FDA P2 PrEP Trial Update – 2021 ?
- Mexico NIH – ?
- Israel MOH – ?
HIV Manuscripts
- CD01 P2 Ext-Monotherapy (5 patients 6 years) Dr. Sacha
- Cure Animal study Dr. Jonah Sacha
- CD02 P3 With primary endpoint achieved
- CD03 Phase 3 Ext-Mono (~215 - 1 year, 40 2-4 years)
- PrEP – Animal study Dr. Jonah Sacha
Cancer Indications
- US FDA Response to Basket 700mg Change – ?
- Creative Microtechnology Analysis of Basket Trial for BTD – ?
- US P2 mTNBC Trial Update – ?
- US P2 Cancer Basket 22 Trial Update – ?
- US FDA BTD Ruling mTNBC – ?
- US FDA BTD Ruling Basket 22 – ?
- Taiwan Cancer Basket Trial Update – ?
Other Active Indications
- US P2 GvHD Trial Update (Goal: 5 Patients) – ?
- US P2 NASH Trial Update – 1st Patient Nov ?
- US P2 MS Trial Update – ?
- US P2 Stroke Update – ?
- US Alzheimer’s Trial Update – ?
Corporate Items
- Science Advisory Board Update PR – ?
- Investment Bank Update – ?
- NASDAQ Uplist Update – ?
- Next Capital Raise – ?
- Right to Try Act (State-based) Update – ?
Potential Additional Trials:
As reported from time-to-time by CYDY
Phase 2:
- Influenza
- Seizures
- Septic Shock
- Traumatic Brain Injury
- Various Autoimmune Diseases
- IBS Inflammatory Bowel Syndrome
- Psoriasis
- Autoimmune Hepatitis
- US HIV P2 Cure – (see above) 2020-2021
- US HIV P2 PrEP – (see above) 2021
Phase 3:
- HIV Mono Therapy (see above) 2020
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
- UK MHRA Delivery of Data Package – Sept 4
- US FDA Interim 28-Day Completion – Sept 23
- US FDA Combo HIV BLA Type A Meeting – Sept 8
- UK MHRA Pre-BLA Fast Track Meeting – Sept 9
- Philippines Distribution Agreement – Oct 13
- US FDA Interim 195 Readout – Oct 20
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
- Mexico COVID P3 3-Arm Trial w/ Remdesivir
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