Expanded access, also known as “compassionate use” is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. These investigational drugs have not yet been approved or cleared by regulatory bodies like the FDA, and these products have not yet been found to be safe and effective for their specific use.
SpliSense LTD. investigational product, SPL84, is being evaluated in early clinical trials for CF patients carrying the 3849 mutation. More clinical studies are required before “compassionate use” can be considered, therefore, SpliSense LTD. does not currently offer an expanded access program for SPL84. The most appropriate way for patients to access SPL82 is by participating in our clinical trial. Information regarding the ongoing clinical trial can be accessed at www.clinicaltrials.gov (Identifier: NCT06429176).
If you have any questions regarding potential participation in SpliSense’s clinical trial or about this expanded access policy, please contact us.