Gossamer Bio, Inc. is focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval prior to marketing and distribution our products. Gossamer Bio, Inc., on behalf of wholly-owned subsidiaries of the organization, is committed to making investigational products available to seriously ill patients who have exhausted other available treatment options and are not eligible to participate on an active clinical trial testing a Gossamer Bio, Inc. investigational product. The Company will review each request for eligibility to allow compassionate access to a Gossamer Bio, Inc. investigational product that is not approved for any purpose in the country from which the request is intended to be used.
To be eligible for access to a Gossamer Bio, Inc. investigational or unlicensed product, patients must meet the following criteria:
a) suffer from a serious or immediately life-threatening disease or condition
b) have undergone appropriate standard treatments and no longer achieving benefit from treatment and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition
c) are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations
d) meet any other pertinent medical criteria for access to the investigational or unlicensed product, as established by the Gossamer Bio, Inc. clinical or medically responsible individual
e) the patient must be under a physician’s care who is properly licensed and fully qualified to administer the investigational product
Any use of a Gossamer Bio, Inc. investigational product outside a clinical study in any country must be in accordance with local laws and regulations governing such programs, including Gossamer Bio, Inc. policies and procedures. In general, where permitted by local regulation, the investigational product supplied via compassionate access may no longer be provided by Gossamer Bio, Inc. when it becomes available via the local healthcare system.
