Pharmaceutical Regulatory Pathway To Market – Rx CQ-001
Patients Suffering from Epilepsy – Dravet & Lennox Gastaut Syndrome, and Tuberous Sclerosis Complex.
Steps to US-FDA and Heath Canada Approvals
Obtaining Drug Identification Numbers DIN for Rx CQ-001 Targeting Rx drug candidate for two epilepsy rare conditions.
COMPLETED STEPS
- CanaQuest Scientific Partnership Network
- Completed pre-clinical trials
- Pre-approved clinical trial programs
- Eurofins: active service provider to obtain Health Canada approvals
- Biopharma Global: Full Service Agreement in place for US-FDA approvals
- Hydrx Farms: GMP pharmaceutical compliance manufacturer. Completing SOPs.
NEXT STEPS TO OBTAIN A DIN FOR Rx CQ-001 – CBD molecules + formula
US-FDA
Work with BioPharma Global and Partners to follow through with:
- Clinical trial (Phase II/III) for epilepsy, Ontario Brain Institute
- Orphan Drug Status designation for expedited regulatory review of Rx CQ-001
- Priority Review Voucher (PRV) which can be sold (extra PRV issued for orphan drugs of rare diseases afflicting < 200k patients and for children)
- Application for Breakthrough Therapy Designation and NDA New Drug Application submitted after clinical trials => US-FDA DIN approval projected ∼ 3 years
Health Canada
Work with Eurofins and Partners to obtain:
- Priority Review Status – achieved once Orphan Drug Status is issued in the USA and if there is no comparable approved Rx drug in Canada
- Priority Review Status is needed for Health Canada’s approval of Rx CQ-001 as a pharmaceutical drug, issuing a conditional DIN under the term Notice of Compliance with Conditions (NOC/c)
- Unconditional Health Canada DIN projected ∼ 2 years
Steps to US-FDA and Heath Canada Approvals
Obtaining Drug Identification Numbers DIN for Rx CQ-002 Targeting Rx candidate as a neurological drug.
COMPLETED STEPS FOR Rx CQ-002
- CanaQuest Scientific Partnership Network
- Research and pre-clinical trials completed
- Ready for establishing clinical trials
- Eurofins & Biopharma Global: active service providers to obtain Health Canada & US-FDA approvals
- Hydrx Farms: GMP pharmaceutical compliance manufacturer. Completing SOPs.
NEXT STEPS TO OBTAIN A DIN FOR Rx CQ-002 – THC molecules + formula
Work with Eurofins and Partners to follow through with:
- Clinical trial (Phase II) for efficacy and dosage, Rx CQ-001 & Rx CQ-002 separately and combined, University of Montreal
Work with Eurofins and BioPharma Global to:
- Review CanaQuest’s regulatory strategy and identify gaps
- Advise on regulatory pathway for Rx CQ-002
- Submit clinical trial applications, working in conjunction with the scientists and regulators.
- Advise on regulatory process and issues with the US-FDA
Projected ∼ 2.5 years for Health Canada approval following the Clinical Trials Application (CTA) – building on vast pre-existing data on THC cannabinoids.