Policy on access to unapproved medicines

At Micelle, ensuring the well-being of the patient communities we serve is our highest priority. All investigational medicines have potential benefits and risks; without carefully designed, well-monitored clinical trials, it is not possible to know how much benefit, if any, there is, what the potential risks may be, and how to balance the risks against the benefits.

We design our clinical trials to provide the highest level of oversight and protection for the participants; study protocols are reviewed and approved by independent review boards, each patient is closely monitored by his or her study physicians, and, in many cases, an outside safety monitoring board regularly review reports of adverse events during the trials. Micelle’s clinical team oversees the overall conduct of each study.

We believe the quickest way to make new medications available to the greatest number of patients is to complete the necessary clinical trials and obtain the data needed for review and approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA). Therefore, we do not currently provide access to unapproved, investigational medicines to patients outside of our clinical trials process in the United States. Our goal is to make new medications available to all patients who might benefit from treatment as quickly as possible once regulatory approval has been received.

Micelle is currently conducting a clinical trial on SC411, see clinicaltrials.gov: Clinical Trials

The investigational product, SC411, is currently not being provided for expanded access use.