Leverage

Consider that our fee is insignificant. Once you achieve FDA approval the value of your invention can easily quadruple.

Look at the financial aspects of achieving Financial Leverage of Regulatory Approvals. The value of obtaining an FDA approval become much clearer.

For the cost of our fee you could sell your product in the U.S. at a markup of possibility 40% to 60%.

If you were to permit a U.S. company to submit your product or drug you would save our fee but could only sell through them at a 15% to 25% markup (and you would be locked into that company, indefinitely). Most U.S. companies would also require you to agree to an indefinite non compete agreement meaning you could not later enter that product into the U.S. market on your own. Consider the per unit cost your product and your estimated selling price. Simple calculations would suggest our approach would yield a much higher return than your investment in us.