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Which way to go: CE Mark of FDA Approval

  1. CroMagnon

    264 Posts.

    I know it is an article from 2012 and from past experience I expect to be belittled because it is outdated or may not apply in TIS's case or ... or..... Belittled in the same way and by the same posters who never ever thought the inventory, or a part thereof, would need to written off. Of course, the very same posters are now seeing the write-off as a positive. And the FDA approval process as a walk-through when compared with EMA process.

    For the die-hard uprampers et al: FDA approval is a long and protracted process.
    Pay attention to the third paragraph, the one that says:
    "From a timeline perspective, there is generally a one- to three-year delay in launching new medical devices into general clinical practice in the U.S. compared to in the E.U. This is partly because the regulatory process in Europe is less bureaucratic, more efficient, and more predictable than in the U.S. Another reason is that the FDA requires evidence of both safety and efficacy of a device, whereas a European CE Mark only requires proof of safety and that the device performs in a manner consistent with the manufacturer’s intended use. Additionally, it’s becoming ever more difficult and arduous to conduct clinical trials in the U.S. due to the FDA’s clinical data requirements. Thus, the timeline for obtaining a CE Mark is typically much shorter than the timeline for gaining FDA regulatory approval."

    Just a reminder: Management (and friends of management) does/do hold shares in TIS - so do I and possibly you.
    IMO: The CR was done this way because every eligible everybody - and that includes management (and friends of management) can get their share. It's that easy - in a institutional only we (possibly you, I, management, friends of management) would have got nothing. Management (and friends thereof) have to look out for each other (and there are other shareholders to think of too).

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