US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
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<strong>505</strong>(b)(2) Risks• Imprecise development costs <strong>and</strong> timelines– ANDA‟s have few re-do‟s of BE– Recruitment of patients not naive– Uncertain dose (Phase 2)• Unknown competition– Other companies can target the same opportunity20
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