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Re: natures garbage man post# 58867

Monday, 07/22/2013 3:37:23 AM

Monday, July 22, 2013 3:37:23 AM

Post# of 75926
I still haven't found a pink who has FDA & CE mark and trades under .05, so I'm assuming if there ever was they exited via merger/acquisition ( sticky report seems very accurate with 95%).. Thats pretty good odds. Let me know if you can find one.

"More than 400,000 women around the world are thought to have had breast implants that were manufactured by Poly Implant Prothese (PIP). The company was shut down in 2010 after it was found to have used substandard industrial-grade silicone gel in its products."



This was the change in the CE Mark requirements or say process that increased cost for SNDY and also delayed the time expected. Good to know SNDY had reasons to raise capital, and the delay was only because the process changed. Im glad thats all over and done with and they survived, with weeks away from becoming a global distributor.

With that, the French and European authorities have been evaluating the approval system in the EU. The indication is that the EU will now be stricter (insert bureaucratic) in the approval process. This will be brutal on the emerging technology, U.S. based companies that have been seeking CE Mark in the EU as part of their game plan to at least demonstrate adoption rates by physicians and also generate sales to offset their burn rates as they eventually work for U.S. approval. Delays in receiving CE Mark with some of these startups will mean millions of dollars of funding being “burned” up as decisions wait to come out of the responsible regulatory bodies in the EU.



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