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I would say the ubiquitous “it depends”. Are you going to file the 22 month data or hold it in reserve, and what is your confidence in a good micro outcome at 24 months? (Do you have other batches that came through with flying colors at 24 months?) Your internal regulatory folks may have some expectations,based on experience with their official counterparts or a strong conservative philosophy. In making this decision, be sure that you have the backing of Regulatory and Quality Assurance. No need to go down alone if your choice goes south. I would love to hear what others think. We’re in need of a good article on what should be done around these additional “expiry date” time points.
