HDG: Thanks for the cool art links. I had not heard of Zoltan Kemeny before, but I do like the sand and gravel sculptures - some look like honeycombs or columnar basalt. A very masculine ethos but via the lens of openings...which is the positive and which is the negative space- interesting. The Maria Kilf and Patricia Kaliczka works look cool, too. I see Budapest is a 2 hour flight from say Brussels or Paris. I may have to visit Budapest (never been before) late this spring - I have a couple of trips to Europe in Q2 and can tack on an extra day or 2 before heading home. Will Budapest be drinking tea with jam by then?
Yes, you got it- that's exactly the bit - that section corresponds to FDA current guidance to industry - they've reaffirmed it. It's hard to say with your specific letter and I don't know all the background of the company (never heard of them), etc that you linked to from 2014, what was going on behind the scenes between the FDA and them. Maybe you have the background? Anyway, there may have been other problems and the FDA chose to "crack down" on that "synthetic" rationale since it was available. Kind of like Al Capone getting nailed for tax evasion. Without digging into it, I can't say, but given current guidance and my read of the political landscape that's why I hold my grey zone define by concentration level viewpoint as a way through the thicket. I am comfortable saying that as of today, the FDA has not changed its guidance to industry and couple that with the FDA moving at a glacial pace like most large organizations...
TOSCA's find of last week's DS working group announcement was interesting because the big trend right now like in my reindeer post with the videos and CO2 supercritical equipment on Saturday is CBD oil. I've heard that sales doubled last year and tripled from June on, of this year, with CBD oils for some apothecaries. It was the "HOT" trend at Supply Side West which means it will be at the European nutra and cosmetics trade shows, too. Because the FDA sits at the Federal level then it makes sense they are going to focus on enforcement because a lot of the growth is happening at the state level. So, here we have another grey area just like in the regulatory framework surrounding DSHEA, but with CBD its state vs federal legality. I've also heard that credit unions have been branching out specifically to handle marijuana monies now, too.
I was trying to think of another analogy to the fishoil apart from the apples. In the US I can buy McCormick's vanilla extract: made from synthetic vanillin, which used to be from the sulfite pulping process in wood pulp. Now, its made from petrochemicals or micro-organisms. Or if I want pure vanilla extract (defined between industry and the FDA as minimum 35% pure vanilla) then I can buy that as well. I could make it by mashing up the vanilla pods and adding ethanol and water. That's "pure" vanilla extract. Nobody has done this that I know of but I could start a marketing biotech company, hire out all the different business functions, list shares to fund the preclinical research, Phase 1,2,3 CTs and assuming statistically significant benefit was shown for a clinical condition- I'd have a new drug. The generic name might be vanillin ethyl. And I could trademark "OlfactaVAN" and say its used to treat HSDD.
That was just a quick one off the top of my head. We'd find with "OlfactaVAN" that we have a clinical purity level to treat a diseased patient population and we'd still have vanilla extract either "pure" or "synthetic" in the supermarket for regular consumption.
AMRN needs HOT sales and marketing of Vascepa and the expanded label will help in those regards.
**Did anyone else see in the news today that two former executives of Wilmington Trust were actually sentenced to jail for securities fraud? Appeals pending though, but of course.
AI
