Even if we obtain human data to support our product candidates, the FDA or comparable foreign regulatory authorities may lack experience in evaluating the safety and efficacy of product candidates like those developed using our platform, which could result in a longer than expected regulatory review process, increase our expected development costs, and delay or prevent commercialization of our product candidates
While these belong to the same drug class as Rybelsus, individual responses can vary, and some people tolerate one formulation better than another
Rachel Schmidt, a research professor at Georgetown University's McCourt School of Public Policy, told CNBC that the $50 monthly copay for GLP-1s "will not count toward a patient's Part D deductible, or the $2,100 annual out-of-pocket cap on prescription drug costs." For a beneficiary on the medication for a single calendar year of the demonstration, that amounts to $600 in out-of-pocket spending that does not count toward Part D's catastrophic coverage protections
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