NZ company - tissue repair product, page-7

Well Koesner here is a little fact for you. Its the company (not BSI) who nominates what it wants its product listed under. TIS chose (pushed for) rule 8. ( BSI said "yea that's fine with us!) And EVERYTHING that has followed is a consequence of this decision. At the time (pre PIP) saga-(industrial silicone breast implants)) it was a good risk that it may have squeezed through, but it didn't and eventually blew up in TIS's face. Sorry about the Inconvenient Truth. You can't change history, even if you don't want to see it. Its all been explained before in intimate detail which I guess a lot of the "new guys" aren't aware of. So be it. My cat knew it was never a Rule 8, never in a million years. The EMA know as well, and see it for what it was, as an attempt to get in the back door. Of course they aren't smothering TIS with kisses after seeing what happened. Because its been this sort of thing that has resulted in EMA getting their asses kicked for incompetence after the PIP event resulted in a focus on their activities. Its called incompetence. Trying Rule 8 was an incompetent risk. Boom. Yes its a long time ago now, but same guys driving the ship. If you don't say "I see what you did and am watching" then expect more of the same.