1. Most Discussed
  2. Gainers & Losers
TIS 0.0¢

Which way to go: CE Mark of FDA Approval

  1. CroMagnon

    264 Posts.
    3
    http://www.mdtmag.com/articles/2012/02/which-way-go-ce-mark-or-fda-approval

    I know it is an article from 2012 and from past experience I expect to be belittled because it is outdated or may not apply in TIS's case or ...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).

DISCLAIMER:
Before making any financial decisions based on what you read, always consult an advisor or expert.

The HotCopper website is operated by Report Card Pty Ltd. Any information posted on the website has been prepared without taking into account your objectives, financial situation or needs and as such, you should before acting on the information or advice, consider the appropriateness of the information or advice in relation to your objectives, financial situation or needs. Please be aware that any information posted on this site should not be considered to be financial product advice.

From time to time comments aimed at manipulating other investors may appear on these forums. Posters may post overly optimistic or pessimistic comments on particular stocks, in an attempt to influence other investors. It is not possible for management to moderate all posts so some misleading and inaccurate posts may still appear on these forums. If you do have serious concerns with a post or posts you should report a Terms of Use Violation (TOU) on the link above. Unless specifically stated persons posting on this site are NOT investment advisors and do NOT hold the necessary licence, or have any formal training, to give investment advice.

Top

Thank you for visiting HotCopper

We have detected that you are running ad blocking software.


HotCopper relies on revenue generated from advertisers. Kindly disable your ad blocking software to return to the HotCopper website.

I understand, I have disabled my ad blocker. Let me in!

Need help? Click here for support.