TS03 Inc Trust Units TSTIF

RE:objectiveness

[binjo222]

Drrwong, you have given this board a lot of insight and I hope you continue to do so.  Recently, you laid out a good case for the importance of internal stability at this point in time.    
 
But I have a question on the next step forward which is dependent on an external source – the FDA approval of the two duo-scopes.

When the FDA asked for additional data, it was reported on this board that the request dealt with 'wear & tear' on the scopes.  So the sterilization aspect does not appear to be in question.  

I'm wondering, though, if the FDA is looking beyond the technical aspects.  Approving these 510(K)s will be a significant step in moving from HLD to sterilization.  With over 500k procedures done each year with these two scopes, a lot of hospitals will be impacted.  Certainly, as has been discussed on this board, the courts will hold hospitals to a higher standard if a patient is harmed by a duo scope which was not sterilized when it could have been.  

There are hospitals in the US (especially in rural areas) which are not in good financial shape.  They probably don't have it in the budget for a new piece of capital equipment.  Since you have a feel for the FDA's inner workings, my question is how much (if any) of this 'bigger picture impact' does the FDA take into account?  Is the FDA trying to come up with an overall timeline or framework for moving from HDL to sterilization?

If the FDA is only looking at technical issues, we should hear relatively soon.  If they are looking at the broader impact, it will take longer.  But in the end a new de-facto standard is what will give our sales force (ours and Getinge’s) some real traction.