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To succeed, one must move beyond the billion-dollar gamble of the new molecular entity and embrace the surgical precision of the 505(b)(2) pathway

This paperwork burden is real and can delay approval by weeks

Kapitza, C., Dahl, K., Jacobsen, J

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And another refereed study released earlier this year by the Journal of Managed Care & Specialty Pharmacy revealed that 72% of individuals who started on GLP-1s for obesity were no longer taking them after one year