Updated and substantially revised with individual categories.
Potential Catalysts w/ Est. Dates 8-22-2020
COVID CD10 Mild / Moderate
- US FDA EUA Unmet Need Response – Soon
- UK MHRA Response – Soon
- Mexico NIH Response – ?
- 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
- UK MHRA Enrollment – Very Soon
- US FDA Interim Enrollment (195) – September 1
- US FDA Interim 28-Day Completion – September 28
- US FDA Interim Results (2-Weeks) – Mid October
- US FDA Interim EUA Submission – ?
- US FDA Interim EUA Response – ?
* The US FDA may demand full completion of Phase 3
COVID Miscellaneous
- Dr. Patterson Peer Reviewed Paper – Soon
- Journal Article by Trial Doctors – ?
- Dr. Seethamraju Paper - 11-Patients – ?
- Dr. Yang Paper - 29-Patients – ?
- Dr. Agresti Paper - 4-Patients – ?
- US OWS / Funding / Grants Update – August/September
- Worldwide Pharma (5) License/Partnership Update – August/September
- Regional Pharma License/Partnership Update: Brazil, China, India, Europe, Middle East, Northern Africa – August/September
- Samsung Biologics Shipment Update – August/September
- Mainstream Media Update – August/September
- IncellDx Companion Assay Kits Update – August/September
- Brazil ANVISA COVID Trial Update – ?
HIV Indications
- US FDA Combo HIV BLA Type A Response (w/Mono Guidance) – September 4
- UK MHRA Combo HIV Pre-BLA Meeting – By September 20
- US FDA Combo HIV BLA Re-Submission (w/Mono?) – ?
- US HIV Cure Trial Update – ?
- US FDA Combo HIV FDA Approval (w/Mono?) – ?
- US HIV PrEP OHSU/Sacha Animal Study Completion – August 2025
Cancer Indications
- US FDA BTD Cancer Meeting: mTNBC + Basket 22 – September
- 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 September
- GvHD Trial Update – ?
- Alzheimer’s Trial Update – ?
Corporate Updates
- Science Advisory Board Update PR – September
- Investment Bank Update – September
- NASDAQ Uplist Est. Date – September
- Larger Capital Raise After Uplist – ?
Potential Additional Trials for 2020:
As reported from time-to-time by the company
Phase 2:
- Influenza
- Stroke
- Septic Shock
- IBS Inflammatory Bowel Syndrome
- Psoriasis
- Autoimmune Hepatitis
Phase 3:
- US COVID PrEP
- US COVID Long Haul
- HIV Mono Therapy
Completed Catalysts
- Dr.BP Manuscript 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 – August 12
- SEC 10k & Audited Financials Complete – August 17
- Mexico NIH P2 M/M Submission – August 17
- UK MHRA P2 M/M “Fast Track” Submission – August 19
Back-Burner Catalysts
- Dr.BP Manuscript #2 Pre-Print
- Dr.BP Manuscript #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 8-22-2020
COVID CD10 Mild / Moderate
- US FDA EUA Unmet Need Response – Soon
- UK MHRA Response – Soon
- Mexico NIH Response – ?
- 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
- UK MHRA Enrollment – Very Soon
- US FDA Interim Enrollment (195) – September 1
- US FDA Interim 28-Day Completion – September 28
- US FDA Interim Results (2-Weeks) – Mid October
- US FDA Interim EUA Submission – ?
- US FDA Interim EUA Response – ?
* The US FDA may demand full completion of Phase 3
COVID Miscellaneous
- Dr. Patterson Peer Reviewed Paper – Soon
- Journal Article by Trial Doctors – ?
- Dr. Seethamraju Paper - 11-Patients – ?
- Dr. Yang Paper - 29-Patients – ?
- Dr. Agresti Paper - 4-Patients – ?
- US OWS / Funding / Grants Update – August/September
- Worldwide Pharma (5) License/Partnership Update – August/September
- Regional Pharma License/Partnership Update: Brazil, China, India, Europe, Middle East, Northern Africa – August/September
- Samsung Biologics Shipment Update – August/September
- Mainstream Media Update – August/September
- IncellDx Companion Assay Kits Update – August/September
- Brazil ANVISA COVID Trial Update – ?
HIV Indications
- US FDA Combo HIV BLA Type A Response (w/Mono Guidance) – September 4
- UK MHRA Combo HIV Pre-BLA Meeting – By September 20
- US FDA Combo HIV BLA Re-Submission (w/Mono?) – ?
- US HIV Cure Trial Update – ?
- US FDA Combo HIV FDA Approval (w/Mono?) – ?
- US HIV PrEP OHSU/Sacha Animal Study Completion – August 2025
Cancer Indications
- US FDA BTD Cancer Meeting: mTNBC + Basket 22 – September
- 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 September
- GvHD Trial Update – ?
- Alzheimer’s Trial Update – ?
Corporate Updates
- Science Advisory Board Update PR – September
- Investment Bank Update – September
- NASDAQ Uplist Est. Date – September
- Larger Capital Raise After Uplist – ?
Potential Additional Trials for 2020:
As reported from time-to-time by the company
Phase 2:
- Influenza
- Stroke
- Septic Shock
- IBS Inflammatory Bowel Syndrome
- Psoriasis
- Autoimmune Hepatitis
Phase 3:
- US COVID PrEP
- US COVID Long Haul
- HIV Mono Therapy
Completed Catalysts
- Dr.BP Manuscript 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 – August 12
- SEC 10k & Audited Financials Complete – August 17
- Mexico NIH P2 M/M Submission – August 17
- UK MHRA P2 M/M “Fast Track” Submission – August 19
Back-Burner Catalysts
- Dr.BP Manuscript #2 Pre-Print
- Dr.BP Manuscript #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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