PPP001* – Smokable Bio Cannabis Pharmaceutical

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PPP001

 

A prescription controlled drug for management of uncontrolled pain in cancer and AIDS patients and patients with Rare Disorders (Orphan Drug).

  • Type B pre-IND meeting with FDA scheduled January 2017.
    – Discussion of road map to market.
  • Submitted two applications for Orphan Drug Designation.
    – Protecting markets with 7-year exclusivity.
  • Submitted Request for Designation to FDA to obtain binding confirmation of regulatory path and requirements.
    – Nov. 8th 2016: FDA confirms Combination Product status with jurisdiction assigned to CDER, FDA.
    – Maximizing exclusivity and protecting market.
  • Secured supply of GMP source of medical marijuana & ability to address CMC requirements of 505(b)(2).
    – A key Language for FDA and physicians.
  • Phase I trial – Pharmaceutical safety study in healthy human volunteers.
    – Defining the benefit to risk for human subjects.
    – Conforming to a first significant issue for physicians & 505(b)(2).
  • Phase II-III and Expanded Access Program – Canada-USA initiated in Q3 2017.
    – Substantial evidence of effectiveness
  • Based on regulatory precedents, anticipating submissions for marketing approval in Canada and USA in early 2019.