Actually the link provided by TDA yesterday on "unsafe or inefective devices approved by EU but rejected by US FDA, gives some insight, maybe, into the state of paralysis we are seeing. A possible understanding but no excuse for seemingly doing nothing, (In absence to facts on the reality of what is actually happening, which TIS seems not privy to as well).
I hope to read the other links provided shortly and hope they are as telling.
TIS Price at posting:
44.0¢ Sentiment: Hold Disclosure: Held