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Thursday, June 18, 2020 6:37:12 AM
Thanks for posting..I agree this is the lynch pin of where Du went off the rails and into the chasm..Obvious is a subjective term..what is obvious to Albert Einstein..might be unfathomable to the rest of the population..
History including medical history is rife with ideas and notions which were at one time considered obvious and were later debunked..Going back 1500 years..The world was obviously flat and was the center of the universe...It was obvious that no machine which was heavier than air could fly..
And in medicine..there is a statement.."The questions never change..only the answers do"..At one it was obvious that amputation stumps should be treated by immersing them in boiling oil..When I first entered Med School..Phlebotomy (bleeding) was still widely practiced and considered the standard of care..Today it is used only in very few situations..Doctors are cautioned about "experimentation"..and the FDA does not approved drugs without objective measurement. The Honorable Judge Du's opinion of obviousness does not accord with FDA's "Marketing Requirements process..there are no free rides..no assumption...No "That's obvious"..It all about the data...Du has simply used hindsight and the MARINE data to support her baseless contention.
This is not reality..The FDA has seen too many "Obvious" notions go down the drain..like Minot and Murphy getting the Nobel Prize for showing that obviously Folic Acid deficiency caused Pernicious Anemia...Later this was shown to be fallacious and that Pernicious Anemia was really the result of Vit B-12 deficieny..By William Castle..
Castle never got his Nobel...
As a play on the old adage.."What would Jesus do ?" Du's opinion is not consistent with what would FDA would do..We already know what FDA thinks about "Obvious"..Its not in the FDA's lexicon...In the FDA..It's "Show me the Data..Without statistic significance in a peer reviewed and accepted
Trial..A drug has no status..All the legal profession notions about "obviousness" are no more important than how many angels can stand on a head of a pin...Its just mental masturbation..Using Graham..(which is about a plow design)..to argue obviousness in a clinical drug..elevates stupidity to a new high..
The law is an ego maniac..Listening to judges discussing medicine is no different than listening to Doctors discussing the law..Very few doctors could pass the bar exam and very few judges could pass the state medical exams..
":>) JL
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