New MD&A document On February 23, 2022, the Company announced that it had entered the United States pharmaceutical market with the completion of an FDA Drug Master File process for pure natural CBD APIs. The DMF allows for the registration of APIs with the FDA for commercial opportunities in pharmaceutical development, novel drugs, and generic drugs. This is a first for CBD by a Canadian company and the second natural CBD DMF at commercial scale in North America. The DMF enables MediPharm to supply approved APIs to pharmaceutical companies conducting late-stage research. The FDA has conducted an active review of the DMF filing. Full acceptance of the DMF filing by the FDA will be gained if a pharmaceutical customer completes a successful filing with the FDA for a New Drug Application (“NDA”) or Abbreviated New Drug Application (“ANDA”).
MediPharm has international pharmaceutical partners who have referenced the DMF and finished goods in either a drug product filing or FDA investigational NDA. If any of our pharmaceutical partners are successful in their United States (“U.S.”) filings, any resulting drugs containing cannabis would gain marketing authorization (through an NDA or ANDA). The drugs would be distributed across the U.S. as FDA approved pharmaceutical products, and therefore outside of any U.S. cannabis regime regulated at the state level. Seeking FDA approvals for both branded (NDAs) and generic (ANDAs) drugs and participating in Phase 2 and 3 clinical trials are long term investments and success is not guaranteed. See “Cautionary Note Regarding Forward-Looking Statements”, “Disclosure for Issuers with U.S. Marijuana-Related Activities” and “Risk Factors”.
The statements regarding intended expansions, exports, distributions, GMP certifications and the DMF
filing are forward-looking statements. The current term of the Licence ends on September 28, 2026. It is
anticipated by our management that Health Canada will extend or renew the Licence at the end of or prior
2
to the end of its term . See “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors”.