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TS03 Inc Trust Units TSTIF



GREY:TSTIF - Post by User

Comment by ElanS2on Jun 15, 2016 2:51pm
141 Views
Post# 24968326

RE:RE:RE:RE:RE:RE:RE:RE:Report coming

RE:RE:RE:RE:RE:RE:RE:RE:Report comingVoila gentlemen. The answer to my question from a previous NR:

In December 2015, TSO3 announced that it had completed studies in order to support expanded use of the STERIZONE® VP4 Sterilizer in the U.S. and had filed for such claims with the U.S. FDA. FDA clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for multi-channel endoscopic devices such as colonoscopes. The expanded claims sought in the U.S. represent similar claims for the STERIZONE® VP4 Sterilizer available in Canada and Europe. 

So the clock has been running since December. So much for the FDA respecting their 90 day "rule".
I always say that the best rules are the ones that you can break if necessary.  The FDA must agree with me.
Anyway all I take away from this is that we could get approval this month, next month , the month after next month  . . . ..
Your guess is as good as mine.
The fact that the requested additional information has been furnished is good.
The ball is in the FDA court now.
I believe that the next communication from the FDA will be acceptance of the claims.
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