Yes. The manufacturer is not required to offer the drug outside their clinical trials, and therefore may choose not to do so. For example:The company may not have enough of the drug available for all patients requesting expanded access and may either establish a lottery system to determine which patients will have treatment access or make the decision on a case-by-case basis.Oftentimes small companies do not have any extra product to give outside of the clinical trial, and expanded access requests would siphon away product from the clinical trials.Companies are also concerned about adverse events in patients not in the clinical trials affecting the FDA’s review.Companies are only allowed to charge to recoup certain research and development costs.