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Bio - Good luck finding a stock more under-priced, more de-risked, and with brighter prospects than Amarin.
North - I didn't interpret this email as meaning V shouldn't be used now, but that there are additional interesting trial results to come.
PE - One of co-authors of the NEJM editorial email Matt Herper that he thought V should be used. Matt included it in his Nov 20 follow-up article.
From Forbes online Nov 20:
"Should doctors use Vascepa? “They should use it,” Kastelein wrote via email. “The only thing we are waiting for is to learn whether Vascepa is unique or other fish-oil preparations or other doses of EPA have less, similar or better efficacy.”
Zu - I tweeted Betsy too a few minutes after her WSJ article launched. My wife emailed her too. I suggested she contact prof Bhatt. Haven't heard back from her, but Dr. Bhatt liked my tweet.
tweet to Betsy from WSJ
ILT - To answer the question of whether the LDL increase in the placebo arm indicates MO caused excess events and exaggerated RI results, it suffices to show the placebo arm subjects whose LDL increased did not have excess events, and that was shown.
OT - Accepting suggestions for what to name my new pet 5.5 pound lobster. Don't spend too much time thinking about it, it will be a moot point after dinner time.
Kiwi - I applaud your attempt to cite science, really, but this "trial" only had 12 subjects total, 6 per arm. It's inconclusive, probably just a student practicing their skills, and the tiny number of subjects should be mentioned if citing it.
Kiwi - I seem to remember you saying, with AMRN around $3, that if RI was successful, AMRN might go to $6 or at most $9, and you thought the chance of success was no more than 50%.
BTW, I'm the world's top expert about what I can't think of. I don't follow the stock you mentioned.
You say you read my SA article, so you know my basis for AMRN value. I don't think very many stocks have just created the dawn of a new era and not been recognized for it yet because of mis-reporting.
ILT - "I can't think of a more derisked investment"
me either
Cardio - If true that only patients resembling RI subjects are eligible, that would be unfortunate, and would kill a lot of people. Benefits spanned pretty much all subgroups implying a large market that would benefit. Strong benefits at high and low ends of the range of trigs means patients with lower trigs would benefit. Many modes of action (the majority) unrelated to trigs. Ditto for diabetic vs non-diabetic, secondary vs primary, etc.
Most people over 50 would very likely benefit IMO, including those not on statins, and there's very little downside.
Kiwi - I think the long version of Dr. Mason's video addressed that, toward the end (after 18 minutes in). Don't have the link handy right now, it was posted recently here. As I recall, oxidation was not considered desirable.
"honest respectful informed posts" - sounds good. Promise?
North - I'm way behind reading the board. Your post about obesity etc made me wonder what the BMI changes were in both arms of RI. NEJM only gives it at baseline. Makes it look like maybe they're holding it for a follow-on paper. I hope they publish follow-on papers soon. Your results are remarkable – DES and weight etc. Did you take steps to lose weight other than V? The 3 year delay seems a bit long.
"V is too good to fail."
Damn straight
Biobill - Agree Herper played a big role killing AMRN stock after AHA, with help from AF. Other media picked it up but left out some of the hedging and came across even more negative (e.g., nasdaq site). Inexcusable given the clear science, even though Herper included (not prominently enough or strongly enough) that it might end up being a real breakthrough. In fact, it WAS a clear historic breakthrough.
Another of your points I agree with "we all got baggage"
"There are lives in the balance..." [regarding prompt FDA approval of V label expansion]
A little simple math - Assuming 10M prescriptions after ramp-up (that's very conservative), absolute risk reduction for CV death is 0.9% annual so lives cost by delay would be 90,000/year, 7500/month, 250/day. Number of preventable heart attacks (fatal or non-fatal) due to delay, with 2.6% absolute risk reduction, would be over a quarter of a million per year. Not to mention strokes.
The later the approval, the later the ramp-up. The 5 year delay during RI seems like about enough (probably about a million preventable events, about a fifth of them fatal). A quick temporary approval of a temporary label seems like the decent common sense thing to do, reducing the carnage while FDA takes probably close to a year to grind out the final form of the label. It would be an unusual thing, not holding my breath, but it would be worth a little out of the box thinking to save that many lives and that much suffering.
Does anyone have the full text of the Nov 10 Adam Feuerstein article on RI? Its pay-walled and I only seem to have the first few words. I may try to do something useful with it. I have the Nov 12 AF follow-up article.
sts - Are you sure Amarin loses money when the coupon is used? I thought it just reduced the co-pay, and they still get a substantial payment from the insurer.
sts - Thanks. For now at least, I think the SA article is free. They do require a subscription, which is free. Not sure when it might go behind a paywall, or if I have any say in that. I'll try to find out.
Perspective - Looking at the 90 year chart of the S&P 500, recent volatility doesn't seem like the end of the world.
S&P500 90 year chart
AMRN is de-risked. Wall Street will figure that out at some point.
I believe the coupon reduces co-pay, there's another payment from insurer.
Thanks Kiwi, and everyone else.
The changes requested by SA editor were almost all format only (references etc) and add comments on valuation. Almost all the changes were from me, my wife (a media-relations pro) and ihub posters, especially TTE's good advice to re-order the sections. Thanks to TTE and others with useful comments I incorporated.
Got about a thousand page views in the first couple hours, seems well-received.
BioChica - It's already there, in the section headed "Vascepa, and why it exceeded expectations", a link including the word video.
Thanks for the congratulations on my SA article. I guess I set the bar a bit low hoping to triple my 2 page views before lunch. I didn't eat yet and over 400 views. Looks like the editor introduced a few typos. I'd said price was under $20 and under got omitted. It would be nice if the market corrected that error this afternoon.
My first Seeking Alpha article just went live. So far I have 1 follower (my wife) and 2 page views (my wife and me). Hoping to triple that by lunch time. Lots of changes from the early draft I posted here. I have realistic, limited expectations, but hope it helps correct misconceptions for some people, and I include numerous links to pages on the Amarin website that will hopefully increase their traffic a bit.
link
mc - I got a feeling you're going to have a very good year. I'd be curious to hear what you think of robinhood when you've had some experience with it. Seems to be popular with millennials.
mclim - That put thing sounds like fun, but how about just buying shares of AMRN and holding a year or two? It's about the most under priced stock I've ever seen, given the facts, which seem likely to be more widely appreciated before long.
Just a thought.
Good luck
zu - Would have been better if they mentioned V gives much more benefit for much less cost.
oneragman - Thanks. I thought about that ihub reference too but thought I'd try it and they were good sports and didn't mention it.
Ken Fisher added up the maximum possible dollar amount of tariffs and compared it to the size of the economies involved. It was a tiny fraction (unlike Smoot Hawley). I know he'd be grateful if you set him straight. (Total tariffs a few hundred $B max, world economy over $60T.)
SA editor asked for a couple minor changes, mostly just format. I re-submitted, expect it to go live soon.
I don't have real high expectations for impact, SA is essentially un-vetted and mostly junk, with occasional worthwhile things. It's part of an overall strategy.
Ken Fisher added up the maximum possible dollar amount of tariffs and compared it to the size of the economies involved. It was a tiny fraction (unlike Smoot Hawley). I know he'd be grateful if you set him straight. (Total tariffs a few hundred $B max, world economy over $60T.)
SA editor asked for a couple minor changes, mostly just format. I re-submitted, expect it to go live soon.
I don't have real high expectations for impact, SA is essentially un-vetted and mostly junk, with occasional worthwhile things. It's part of an overall strategy.
Kiwi - That may indeed be your wild guess, but you stated it as fact without clear evidence.
Kiwi - Ken Fisher points out that the current "trade war" tariffs, if all the tariffs talked about are implemented (and most of them are probably bluffs or bargaining chips) they are far, far too small to significantly hurt the global economy. Maybe $100-200B in a multi-tens of trillions of dollars economy Markets over-worrying a small issue is very common and very bullish, and that's what we have now (says Ken Fisher). BTW, add role and roll to your list of words to look up.
Biobill - I share your disappointment with past FDA actions, particularly the lack of a fair and open discussion at adcom and failure to give required notice they were changing the rules in the middle of the game. A good case can also be made that, when a drug is safe and has demonstrated at least a plausible case for benefit, that doctors and patients should be allowed to choose whether to try it, with full disclosure of the best available information.
My primary target audience for my article is not really FDA but prospective investors and perhaps some doctors. I intend to use links to it on twitter and engage some of the prominent critics.
io - Thanks for your comments.
I agree, as prof Bhatt commented Nov 10, the MO issue is minor and doesn't really deserve the prominent attention it's been getting. But, critics continue to harp on it, helping hold back stock price and prescriptions. Explaining something does sometimes help bring more attention to it than it deserves, but MO has already been blown out of proportion all over the media.
I gathered and presented all the MO evidence I could find, which overwhelmingly shows the MO effect is very minor. No question it's overkill, but my game plan includes using it to engage some of the prominent critics to try to get them to retract their remarks.
If you take another look, you'll see I did not entirely omit the subgroup analysis from NEJM. Quoting from my posted draft:
"He [Bhatt] also cited an RI subgroup analysis reported in NEJM showing similar risk for placebo subjects independent of whether their LDL rose or fell, which is very strong evidence the MO impact is near zero[2,13,15]. The subjects with increased LDL actually had slightly fewer events. That alone should settle the matter."
Kiwi - I've been "published" many times, mostly top secret and not public, but also government reports.
My article was not intended to be dumbed down.
Marz - NNT is number needed to treat. Smaller is better. It is the number of patients you'd need to treat for a year to avoid one event, on average. Statins, and most other drugs, the number is much higher. A doctor would know that. I didn't know that either until recently.