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Therefore, we recommend that companies determine their regulatory pathway to market in 2025-2026 and consider pre-subs in 2026 to allow time to take action on any FDA feedback before submitting the premarket submission
4 Interestingly, early trials suggested DPP-4 may affect the immune system due to inhibition of T-cell activity in vitro
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The findings were consistent after accounting for age, race, ethnicity, body mass index (BMI), breast density, and diabetes
