The FDA does not rule the world. See the legal history of Pearson vs. Shalala (FDA), here: http://www.emord.com/significant-legal-cases.html I don't expect RCPI to abandon their present wise, cautious, and effective strategy. But others may not be so patient. This is not a prediction; it is only an observation. If you haven't noticed, revolt against overbearing government and crony-capitalism, supported by administrative law, is in the air.