Expanded Access Policy

Clinical trials, and the subsequent approval of a therapy, can provide long-term access to new therapies for patients in need. Patients interested in an investigational product which has not yet been approved are encouraged to speak with their physician to be evaluated for possible participation in Savara’s future clinical trials. You can find information about our clinical trials, including the status of patient recruitment, by searching for “Savara” at www.clinicaltrials.gov. In addition to guidance from the FDA and other regulatory authorities, Savara considers the following general criteria when reviewing requests for access to investigational product outside of a clinical trial:

1. The patient’s diagnosis, presentation of clinical symptoms, and access to satisfactory alternative treatment options (e.g., the patient must have a diagnosis of autoantibody positive autoimmune pulmonary alveolar proteinosis with clinical symptoms and no access to satisfactory alternative treatment options)
2. The patient’s previous and current enrollment status in a clinical trial, including IMPALA-2
3. The potential benefits of treatment with molgramostim versus the potential risks, as determined by Savara’s medical team
   • The medical team may request additional information from the treating physician in order to make this determination
4. The availability of supply of molgramostim to support Savara’s ongoing clinical trial and development program
5. Local country laws and regulations about expanded access

Savara will review requests on a case-by-case basis according to the above stated criteria, and requests for access are not a guarantee that access to molgramostim will be granted. Savara’s policy on expanded access will be reviewed on a regular basis and as more information and clinical data on the safety and efficacy of molgramostim become available. To request medical information about expanded access to molgramostim, physicians should contact medicalinfo@savarapharma.com. All requests must be submitted by a licensed physician. Someone from Savara will respond within approximately 5 business days. Additional information about Expanded Access can be found on the Reagan-Udall Foundation Expanded Access Navigator website.

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