What are the regulatory requirements for TB diagnostics, both in-country and globally?
- What is required for the registration of new diagnostics in the major, high TB burden countries?
- Will multiple regulatory approvals be necessary? What will it cost? Is there a pathway to get simultaneous approvals from multiple regulatory agencies?
- How critical is FDA approval for global markets and what will it take to get FDA approval?
- What are the advantages and disadvantages of getting CE mark versus WHO prequalification versus FDA approval and which of these is needed for major markets?
- How strong is the intellectual property in the TB diagnostics area, and specifically within major, target countries?