Get CE and then sue for two years lost sales is a possiblity.
Its not just giving approval then withdrawing, its the medicine no its a device, its the data not needed for CE now data is needed pre-CE and take the freaking cake we are to busy to process your lawful application.
As Rev has posted the standard they have set for themselves, well they have failed miserably on this application and its on our dollar.
TIS Price at posting:
31.0¢ Sentiment: Buy Disclosure: Held