Drug Development from Inception to Commercialization

Biotech companies can be highly profitable for investors that get in at an early stage.

Drug Development from Inception to Commercialization

The typical timeline for a drug approval from the initial discovery phase all the way to commercialization is 10 to 12 years. It includes the following:
Patent application:
Patents for Canada, the USA and EU approved in 2018/2019.
Basic research and proof of concept: Complete.
Pre-IND meeting and IND approval: Complete.
Toxicology and Animal testing: Complete.
Phase 1 trials: Complete.
Phase 2 Health Canada meeting: Complete.
Phase 2 small cohort trials: Ongoing.
Phase 3 large cohort trials:
NDA meeting:
Health Canada filing/approval:
Submit technical data package:
Phase 4 Post-marketing studies:
Market Launch:

We are in phase 2 clinical trials, which typically takes 6 to 8 years. With proper financing we can complete the remaining tasks in the expected timeline. And because our target indication (C Difficile infection) is considered an “Unmet Medical Need”, it is expected fast track status will be applied by regulators.

A possible exit strategy is after successful completion of phase 2 trials (now ongoing), when larger Pharmaceutical companies can come on board with further financing or complete buyout. Typically the company valuation increases with successful completion of each task.