The Guide to Entrepreneurship

Harvesting ◾ 375

The time-frame necessary to achieve these developmental milestones may

be long and uncertain, and we may not successfully complete these mile-

stones for any of our intended products in development.

Prior to conducting clinical trials, which are necessary to obtain approval

by FDA to market a product, we must obtain FDA clearance. Even after

obtaining clearance, the FDA can halt clinical trials at any time for safety rea-

sons or for any violations, by us or by the clinical investigators, of the FDA’s

requirements for conducting clinical trials. If we are unable to receive clear-

ance to conduct clinical trials, or if our clinical trials are halted by the FDA,

we would not be able to achieve any revenue from such products since ...