TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:RE:RE:RE:News

[Darrow100]

My biggest concern involves the history of TOS's attempts to get validation of their process in the first instance. Long time holders will remember years ago when TOS filed a 510K with the FDA and, after months, the FDA came back and suggested that they might want to reconsider and file it as a De Nova device. TOS did in fact go through the process of  refiling as a De Nova device and after months and wasted $$ the FDA came back and said they would be better filing under the origional 510K designation afterall. Again months of retesting and the refiling process - which overall took many $$ and years more than if they had filed just as a 510K in the first place. I realize TSO3 is now, or should be easily recognized as a legit company / process by the FDA. By the way why is the TSO3 equipment/system not considered a De Nova process by the FDA? - ie: the new  'go to' process for low temp sterlization - or does it not matter now?