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505(b)(2) – Part 2: The Assessment: Timeline, Cash Flows

Once the clinical development plan is established, the CMC, regulatory and medical communication plans can be matched up. We use MS Project to develop a high-level overall plan.  MS Project then can be used to generate cash flows and Gantt charts.  This information can be used by the sponsor to determine if the project is financially feasible.

For each clinical study we consider the overall length and the estimated cost.  Based on the schedule of clinical studies, we can identify when when a batch of clinical trial materials is needed.  For these batches we can then back up and schedule tasks for the formulation and analytical development. In a similar fashion, we can match up the potential medical communication tasks (posters, abstracts, advisory board meetings, publications, etc.).

The overall timeline can be useful to assess the likely approval date.  This date is then compared with the expected approval dates of potential competitive products in the pipeline as determined in the Competitive Products Review section of the Assessment Report.