TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:A Quick Reaction -- FDA Meeting

[ElanS2]

Your comments make sense.
Rumble has made it clear that the data supporting this usage exists. Originally the FDA was evaluating the three cycles as if each was a new device. The new category of equipement created for the single cycle VP4 should make it easy to add different cycles. The basic science is now established and accepted by the FDA and they have a problem on their hands that the VP4 can solve. We will not be obliged to return to the same starting point. In addition to the approval of the VP4 TSO3 received approval for the bio-indicators and equipment trays ( if I recall well ). The FDA may request some additional data, but it will not be like going back to zero. 
Arm yourself with some patience, because if additional tests are required they will take time to get the new data to the FDA. I will be satisfied if new cycles are accepted before the end of the year.
The FDA seems to be unpredictable and slow. Nothing we can do about that.