Expanded Access Policy
Palvella will consider requests from only 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. Treating physicians interested in potential access to investigational products may request more information by contacting Palvella via email at email@example.com. Please note that only requests submitted by treating physicians will be considered. Receipt of a request will be acknowledged within 10 business days. The following criteria will be considered, including but not necessarily limited to:
- Whether the patient is ineligible or unable to participate in an ongoing clinical trial;
- Whether the patient has a serious or life-threatening disease or condition;
- Whether there are comparable or alternative therapies available that would be satisfactory;
- Whether the investigational therapy is currently being studied in humans;
- Whether the patient suffers from a disease or condition that is sufficiently similar to the disease or condition for which a clinical trial is being conducted;
- Whether providing the investigational therapy on an expanded access basis will interfere with the conduct of clinical trials or any regulatory submissions;
- Whether there are sufficient data to show that the potential benefits of the therapy outweigh the possible risks, based on available safety and efficacy data;
- Whether Palvella plans to pursue regulatory approval for the therapy in the patient’s country; and/or
- Whether there is an adequate supply of the investigational therapy.
Because the circumstances of each request are different, there is no guarantee that expanded access will be granted for any of our investigational therapies. Additionally, Palvella reserves the right to deny any request at its discretion. Palvella’s decision on whether or not to grant expanded access to the investigational product under an Expanded Access Program should be communicated to the requestor within 15 business days of receipt. You will find information about Palvella’s investigational therapies at www.palvellatx.com under the tab, “Our Programs” and “Clinical Trials.” If you have questions, please contact us at firstname.lastname@example.org.
Please note: This policy is subject to change at the discretion of Palvella Therapeutics Inc. and subsequently, this web page will be updated to reflect any revisions to the policy.