DEVELOPMENT TIMELINE
Product development path
- Statistically demonstrate the effective release of all active ingredients over a 35-day period in combination and isolation.
- Produce sufficient number of GMP (Good Manufacturing Practice) rings for additional testing (Control rings, Contraceptive, Anti-HIV and Combination Rings)
- Conduct pre-clinical animal studies
- Pre-IND package
- Schedule pre-IND meeting with the FDA
- FDA meeting for their opinion on data compiled to date (re: safety, product efficacy, etc) and learn requirements for human trials/market approval
Estimated timing
- Product development: 12 – 18 months
- Animal studies, etc.: 9 – 12 months
- Preparation/scheduling of Pre-IND meeting: 6 months (concurrent with above)
- Total: 30 – 36 months
What happens next?
- Update BioRings data package in accordance with the pre-IND meeting results/direction from FDA
- Select a clinical research organization (CRO) to conduct human clinical trials
- Produce sufficient vaginal rings for these Phase I studies
- Submit an IND
- Initiate Phase I clinical trials