Clinical Studies

Palvella will consider requests from licensed treating physicians for access to investigational products in development for patient treatment purposes on a case-by-case basis. To advance investigational therapies, clinical studies are conducted to assess a product candidate’s safety and efficacy. After this data is collected and evaluated, the company plans to apply to the U.S. Food and Drug Administration (FDA) and other relevant regulatory agencies to obtain approval to commercially market the product. A company cannot provide patients with broad access to products until the FDA and other regulatory agencies grant approval.