“.. a time to keep silent,and a time to speak.”
Ecclesiastes
Tiresias has spoken ofmany things. He has much more to say. He has prophesied and sees much more besides.At times he might have though, from receptions from some quarters, that he wasCassandra. Tiresias sees more and much further, but today he thought to reflecton on Friday’s announcement from Optiscan.
You see, my friends, propheciestake time. There are behemoths and leviathans which have to be overcome forTiresias’s prophesies to become realities. The Leviathans he speaks of, ofcourse, is the bureaucracy, regulations and the dead hand of the black lettersof the regulatory red tape. Leviathans which threaten to take over the world. Tiresias isreferring the FDA, the TGA etc, which must be satisfied. There is no way to subjugatethese monsters except by wearing them down with time, paper, paper, forms, and still more paper. But don’t despair. TheLeviathan is already slain but needs to be shown that he is slain, yet again. TheFDA has approved Convivo, to be used on the brain, in neurosurgery. The FDA has alsoalready, long ago, approved the confocal endomicroscope, for gastrointestinal use. The GI endomicroscope was an achievement of extraordinarytechnical virtuosity, and has full long ago received full approval. Both these have both FDA also the European CE Mark. But of course, the Australian “mini me of regulation”, theTGA, is still requiring volumes of paper from Carl Zeiss, to approve ConVivo inAustralia, whilst Australian neurosurgeons, Tiresias knows of, who want the Convivo, in Australia now, to use in brain tumour surgery, haveto wait. A scandal? But do not despair. Do not be disappointed by the announcement on Friday, of the pathway of approval of InVivage,which is the same, but better model of the previously approve instruments, but still has to guided be the same bureaucratic labyrinth, abureaucratic madness made even slower by COVIDid 19. It is however approved,all but in name. There is no impediment except paperwork. The voracious bureaucratic leviathan must be satiated by more paper and then some more, to justify his existence. Be patient though, my friends, you are holding on to something which is changingthe world. There are things which can be done and ways around which nothing,not even the dead hand of regulatory bureaucracy can hold back. And they are being done.
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2 | 39552 | 0.083 |
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4 | 117512 | 0.080 |
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Price($) | Vol. | No. |
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