TS03 Inc Trust Units TSTIF

RE:RE:D-Scope update

[binjo222]

echo2, thanks for the thoughtful analysis of the FDA's reply.  

Those selling in a panic now, I think, were swept up in the 'Hollywood' scenario; i.e. TSO3 submits the 510Ks, the FDA approves them no-questions-asked and the SP goes through the roof.  Anybody who believed that doesn't understand how the FDA really operates.

As you pointed out, this is not a 'usual' 510K.  Approval will mean the VP4 has estblished sterilization as a new standard for the most widely used d-scopes.  The FDA must ensure that sterilization can and will occur under all conditions -- new scope, scope with some wear & tear, etc.  It is unrealistic to think the FDA would not have wanted some points furthur tested and clarified.  They may still have some points of clarification going forward.  Remember when FDA finally granted the initial approval with a new product code?  That took several rounds of FDA questions and clarifications, as I recall.  

When this 510K is approved, TSO3 will have a virtual monoply in d-scope sterilization.  Then long term share holders will be glad the barrier is so high for FDA approvals.