Saturday, December 15, 2018 6:17:29 PM
1) Agree the FDA needs to clear up the grey area - especially after R-It results. I was only suggesting a possible way negotiations could happen given my readings and the unlikelihood of the FDA strangling an entire industry that is substantial to Utah's economy.
I could list more than a few examples, but here's a recent ripped from the headlines one. For those unfamiliar with the Jones Act it requires that vessels be built & owned in the US if they are going to operate in the US. But, there are a few rules like under 7.5% foreign steel can be used and a shipbuilder and owner would be OK. The Coast Guard oversees the Jones Act. So, what happens when somebody goes over? Would the USCG have the final say - or would it be politically negotiated behind the scenes and then presented as a done deal on such-and-such a date?
Trump signs Jones Act waiver
There's a technical reading of the law and then there's real world law mixed with politics.
2) Yes, thanks I've been meaning to ask the board or lowlevel what actual patents exist to date on process? Ok, well noted (sadly) that you think there aren't any.
I read one of their patents with a 2017 date? and it did list EPA concentration levels so that's why I connected it that way (but I also have seen krill patents and Pronova patents and they all use the same boilerplate language)...I don't have the time or inclination to cull through all their patents. The marketing angle alone is going to be so tough...
3) Totally agree - Smarterer and I actually discussed this scenario. Let's say AMRN gets a Christmas or New Year's wish. CAFC remands back to ITC. ITC conducts a quick investigation. They find all DS imports are illegal. At that point - I agree with the current US based refining capacity that AMRN would need in X # of years out then the FDA would have to quickly approve some of these smaller refiners. Smarterer had seen instances of government quickly approving in these types of situations which I had also just logically figured - every human organization is political. A few shortage headlines like we've seen with "flu vaccine" and the FDA would spring into action.
4) I personally think O-3s DS are legal. I view them as an entirely different part of the market. Maybe they don't provide much by way of huge benefits - but neither does drinking Coke or eating a Big Mac. That doesn't make them illegal.
Do I think docs or PBMs should tie them to the equivalency of a clinical trial result at a guaranteed clinical efficacy level of purity like Vascepa or in 10 years a generic V? Of course not. As Ziploc said - this is what makes it a legal drug in my view that has been walled off-- by the CTs and FDA NDA approval.
My other reindeer post today - is a visual on "esterification." Mix some alcohol (the non-polar solvent) in the fishoil to pull off the glycerol backbone from the fatty acids.
If I cut up an apple so that it stacked neatly to fit into my daughter's lunch container or better yet, made homemade apple sauce and put some lemon juice in it so that it didn't lose its color, ie oxidize, and then Vitamixed it with some probiotics...that doesn't mean the apple sauce is now a "drug." It's still a food.
I'd have to file for some element of the apple sauce and prove that the compound had a SS benefit, right? I mean, that's the idea behind protection against apothecary quacks of yesteryear.
Some zipped photos and a small video on kitchen esterification -
oil and alcohol
You'll see in one photo 3 small cups with crude fish oil - that have been in the fridge for different amounts of time. The middle and right hand cup are showing cloudiness (crystals are forming for the fatty acids as the temperature drops - use can use these crystals as a processing method to separate, too). The right hand bottle has been in a freezer - it's solidifying. The reddish color is from the krill the fish have been feeding on. You can use bleaching clay, for example, to remove the color - then to our eyes it's a marketing way to say "it's pure" kind of like Dasani water bottles from Coca Cola have that "pzzzt" sound when you open them from using some CO2.
These are signals to our senses that its pure (special). The small video takes some rum, a non-polar solvent (alcohol), to start pushing the esterification reaction of taking the fatty acids from their glycerol backbone and putting an ester in its backbone position instead.
If you have a counter-top water distiller then you could distill the Rum back from the now esterified oil. Or if you wanted to mix and match and you had a small vacuum pump you could separate the bigger molecules and then distill the fishoil to begin "concentrating" the oil. Yes, it's "synthetic." So are rum spiced apple pies I bake. Are they proven to a clinical level of efficacy to cure anything? No, I'd have to run a clinical trial to prove that my apple pies cured missing Mom's homecooking.
You can also try this at home by frying up some bacon. Take the lard or warm oils left after frying and mix with the highest proof alcohol in your liquor cabinet...
JMO - we'll see how it all plays out while waiting for a likely BO. If we knew all the answers ahead of time it wouldn't be half as interesting. So you have an art gallery! How cool. We enjoyed visiting the Peggy Guggenheim Art Collection in Venice last year - some niche and not as well known modern art but by well-known artists. I highly recommend it.
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