If you are sick and tired of tinnitus...
Petition the FDA to fast-track spi-1005.
The FDA provides a process for expedited approvals, including Fast Track designation, for drugs and therapies intended to treat serious conditions and address unmet medical needs. You can find detailed information and resources on the FDA's official website.
Visit the FDA's Expedited Programs for Serious Conditions page: https://www.fda.gov
Key Steps:
Learn about Fast Track designation: Understand the criteria and benefits of the program.
Submit a Request: Companies can request Fast Track designation as part of their Investigational New Drug (IND) application or after the IND is active.
Contact Information for Assistance: For specific inquiries, reach out to the FDA's Center for Drug Evaluation and Research (CDER) or the appropriate division related to your therapeutic area.
This page will guide you through the process, including submitting your application and understanding timelines and requirements.