Case Studies

Camargo Case Studies

Camargo has worked with a number of clients who have initiated 505(b)(2) projects on their own – and with consultants who were new to 505(b)(2) – and have run into missteps. In the following case studies, we document situations we have encountered, and how Camargo helped pull these misaligned projects back on track. Some inconsequential details have been changed to protect proprietary information.

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Case Study 1

A European generic API producer needs to offset declining revenues

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Case Study 2

Knowledge of combination drugs and target markets leads to commercial success

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Case Study 3

This strategy allows for earlier approval and protection against generic competition

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Case Study 4

Full NDA approval without conducting any clinical studies using the 505(b)(2) pathway

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Case Study 5

Mid-tier generic company facing declining revenues and weak outlook due to the generic patent cliff.

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Case Study 6

Using competitor’s product in a Phase 2 trial offsets the need to conduct one of the Phase 3 trials

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Case Study 7

Inadequate use of public information leads to costly study requirements

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Case Study 8

Inadequate use of public information leads to clinical holds