Regulations/Path to Market

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.