- Complete the IND for the conduct of pivotal trials of Zertane™ in the USA as agreed with the FDA. This includes the delivery of the final packaged drug as well as all documentation necessary for registration and approval processes with the FDA and other regulatory agencies.
- Complete the registration package for approval of Zertane™ by the TGA in Australia (based on the completed phase 3 trials conducted in Europe), which will be used for approval in multiple countries, including South Korea and Brazil where Ampio has secured licensing agreements.
- Finalize pricing of Zertane™ for launch in countries outside the USA and provide clarity for licensing negotiations with additional potential partners.
Ampio Provides Update Of Manufacturing Plans For Zertane™
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