Updated but hopefully obsolete (in a positive way) by the
Updated but hopefully obsolete (in a positive way) by the end of the week.
Potential Catalysts w/ Est. Dates 8-19-2020
- US COVID P2 M/M FDA EUA Unmet Need Response – ?
- US COVID P2 M/M EU, Philippines, Israel Submissions – ?
- US COVID P2 M/M Journal Article by Trial Doctors – ?
- US COVID P3 S/C Interim Enrollment (195) – September 1
- US COVID P3 S/C Interim 28-Day Completion – September 28
- US COVID P3 S/C Interim Results (2-Weeks) – Mid October
- US COVID P3 S/C FDA EUA Submission – ?
COVID NOTES:
The FDA may demand a Phase 3 Registrational for M/M
The FDA may demand full completion of Phase 3 S/C
- Dr. Patterson Paper Peer Reviewed – Soon
- FDA HIV Combo BLA Type A Meeting (w/Mono Guidance) – ?
- Samsung Biologics Shipment Update – August/September
- Science Advisory Board Update PR – August/September
- Mainstream Media Update – August/September
- US COVID OWS / Funding / Grants Update – August/September
- Investment Bank Update – August/September
- IncellDx Companion Assays Update – August/September
- UK COVID Trial Update – ?
- UK Combo HIV Pre-BLA Meeting – ?
- Brazil COVID Trial Update – ?
- Other Countries Express Interest – ?
- Worldwide Pharma (5) License/Partnership Update – August/September
- Regional Pharma License/Partnership Update: Brazil, China, India, Europe, Middle East, Northern Africa – August/September
- NASDAQ Uplist Est. Date – August 22 (+/-)
- Larger Capital Raise After Uplist – ?
- Combo HIV BLA Re-Submission (w/Mono?) – ?
- US BTD Cancer Meeting: mTNBC + Basket 22 – September
- Dr. Seethamraju Paper - 11-Patients – ?
- Dr. Yang Paper - 29-Patients – ?
- Dr. Agresti Paper - 4-Patients – ?
- mTNBC Trial Update – ?
- Cancer Basket 22 Trial Update – ?
- MS Trial Update – ?
- NASH Trial Update – 1st Patient September ?
- GvHD Trial Update – ?
- Alzheimer’s Trial Update – ?
- HIV Cure Trial Update – ?
- Taiwan Cancer Basket Trial Update – ?
- US Combo HIV FDA Approval (Mono?) – ?
- HIV PrEP OHSU/Sacha Animal Study Completion – August 2025
Potential Additional Trials for 2020:
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
- US COVID P2 M/M Mexico Submission – August 17
- US COVID P2 M/M UK 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 COVID Combo Trial
- US COVID P3 Remdesivir 3-Arm Trial
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