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Gastrointestinal conditions Some gastrointestinal conditions may affect how vitamin B12 is digested or absorbed, such as: history of gastrointestinal surgery celiac disease Crohns disease pernicious anemia infections, such as from Helicobacter pylori bacteria or parasites pancreatic insufficiency or cancer bowel cancer folic acid deficiency small intestinal bacterial overgrowth Vitamin B12 injections may be more helpful for people with gastrointestinal conditions than oral products

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In addition, while the applicant provided background citations to support the assertion that optimal or improved cytoreduction of tumor results in improved survival in ovarian adenocarcinoma, the Phase 3 study of CYTALUX appears to have been designed to assess the efficacy of the technology rather than clinical outcomes such as survival, recurrence, or rate of additional procedures