Great work Dr T and Race Team! $2 here we come.Co Pilot AI...

Great work Dr T and Race Team! $2 here we come.

Co Pilot AI response around the Orphan Drug Designation and Benefits (some written into announcement already)

You: What are the benefits of orphan drug designation?

Copilot:

Orphan drug designation offers several benefits, depending on the regulatory agency and country:

1. Access to the Market: It facilitates orphan drugs’ entry into the marketplace, making them available to patients who need them.

2. Cost Offset: Sponsors receive assistance in offsetting the high costs associated with developing orphan drugs1.Transparent Assessment: The designation ensures a consistent and transparent process for assessing eligibility criteria.FDA-Specific Incentives (US): In the United States, the FDA’s Orphan Drug Designation (ODD) provides tax credits, marketing exclusivity, fee waivers, and access to specialized regulatory assistance

3. Market Exclusivity: Once approved, orphan drugs may receive up to seven years of market exclusivity

4. Remember that orphan drug designation doesn’t guarantee registration on the Australian Register of Therapeutic Goods (ARTG) or other regulatory approvals, but it does offer valuable incentives for drug development and patient access14.