GREY:TSTIF - Post by User
Comment by
ElanS2on May 26, 2015 11:44am
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Post# 23765045
RE:RE:RE:Post FDA meeting article
RE:RE:RE:Post FDA meeting articleImmediately before the start of the AGM I asked Rumble if TSO3 would be making a presentation at the FDA conference. When he replied no I then asked why not. His reply was that the important people were already aware of what the VP4 could do and that internal test data existed. In his presentation later he went into some detail of the lengths and brands of scopes that could be successfully sterilized by the VP4. That is all well and good, but I am disappointed in the derth of references to TSO3/VP4 in the FDA meeting notes that we have seen on this forum. I have not read all that is available from the FDA so perhaps there is something I/we have not seen. I would like to know what TSO3 is doing to reply to the lack of data that the FDA is referring to. Mr. Rumble's hope for the conference was to see the FDA raise it's requirement to sterilisation. So far this has not happened, and the FDA is falling back on the supposed lack of data.
From what I have read on this forum, in the context of the conference, I could conclude that the FDA is unaware of the VP4's ability. In my opinion it is regretable that TSO3 was not at the conference with data in hand. I certainly hope that something is going on behind the scene. Perhaps Mr. Rumble does not want to be seen as pushing the FDA.
TSO3 has a device which employs a disruptive technology. It is also a small company which has never made any money, from a foreign country that speaks a funny language and has funny money. It is a certainty that the major companies in the business will do little or nothing to help TSO3 beat themselves to a market. TSO3 has to stand-up and be disruptive, to shake things up, and make itself heard out in the open. Getinge may be a good step arround the american road blocks, but that will have to be proven and soon. The next quarterly report will be in mid-August.