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505(b)(2) – Part 2: The Assessment: Competitive Product(s) Review

We investigate major factors that influence the potential clinical evidence required and the likelihood of a product’s acceptance in the market.  Having established a working draft of our labeled indication(s), we look at the therapeutic category.  What drugs have been used, are currently used and what drugs are being studied for eventual marketing?

This comparative review serves two major purposes.  First, we are determining the clinical threshold to be met by our new product and second, what is the likely market acceptance.  Clearly, the two objectives are interrelated.  By looking at what clinical studies are being conducted  we can see the design and the primary and secondary endpoints.  Not only will FDA impose at least some of the learning’s from these competitor studies on our clinical program but we learn what evidence will be used by the marketplace (physicians, formularies) to select the products in the near future.

Thus, we provide an assessment of the existence of an unmet medical need and the ability of the proposed drug to compete with existing and pipeline agents.  In summary, we provide:

  • Insight into the market
  • Pipeline overview
    • Products in development
    • Clinical trials in progress (i.e, CenterWatch)
  • Competitor’s Strategy
    • Pricing
    • Patents
    • Diversification
    • In-licensing