Well full disclosure ...I thought 70/30 in favor of approval at Adcom ...based on risk / benefit analysis ....potential for benefit with almost 0 risk .....so I was wrong there.
If expanded label ... An immediate jump to at least 3 ....then the debate will begin on whether or not the Corscia group might convert some of their debt to equity which might involve diluting the stock ...
I'm also wondering if the FDA may loosen their language on all RX fish oils ....so we might see more competition from generic Lovaza.
I try an answer to that
Did not pay for doctor visit ....he emailed in request
Blood draw did cost me about $30
No charge for lipid panel ....guess my insurance covers that.
No doctor visit following ...email discussion on results / review ....no cost.
Yes , did get a prescription
Do not have extremely high TGs but do have a lipid disorder and a family history of heart disease .....so on risk reward basis Cardiologist felt it was worth trying
IMHO ...Amarin will finish RI no matter what
They currently have funds to last to early 2016 when an interim analysis is expected .
I expect Vascepa's label to be expanded to include language that states that CV risk may be reduced by lowering high TG's using Vascepa in patients at high risk .
Wider approval contingent on positive Reduce It read put.
The reason for the change ....recent research in the New England Journal of Med identifying high TG's as a risk factor ....And .....probably over 30,000 patients now on V for over a year and no adverse events
What insurance coverage do you have ?
Are you using Amarins coupon
What's your actual monthly cost ?
Agree that your MD will want the quantity and quality of EPA to be consistent especially at 4 gm dose and if you are considered high risk .....what's your lipid panel numbers and family CV history
Build a home
I agree that OmegiaVia Via EPA is the best alternative for those that can't get insurance coverage for Vascepa .
Some patients using insurance co pays and Amarins coupon get a months supply of Vascepa for $19 ...OmegiaVia EPA will cost about $34 from Amazon including shipping for a months supply ....since it's 88% EPA you will actually need more of it to equal daily dose of Vascepa ....
OmegiaVia Via EPA is regulated as a food ...Vascepa as a drug ...Quality and quantity of EPA is higher in Vascepa
If you are getting OmegiaVia EPA delivered you will need to watch delivery times as the last thing you want is for it left out in the sun all afternoon . Vascepa I get from cold storage at Walgreens
Bottom line ....If you have great insurance copay and Amarins coupon you don't even consider dietary supplement alternative .
If your insurance declines coverage ...OmegiaVia EPA ..provides a lower cost , lower quality alternative
Some what OT ... Those with Hetero FH who are also Statin intolerant face an unmet medical need . Without aggressive treatment as many as 85% of these patients will have a CV event by age 65 ( Medscape )
PCSK9's will be targeted at this group IMHO
Everyone with hetero FH should also be on Vascepa .... to reduce chance of coronary artery plaque rupture.
Most patients with Hetero FH will likely have some amount of coronary artery plaque past age 40.
Hetero FH is about one in 350 in the US.
The PCSK9 is designed more for hetero familia hypercholestremia patients and those intolerant to Statins ...They do not directly compete with Vascepa
PCSK9 's dramatically reduce LDL cholesterol ...hetero FH paints have LDL levels anywhere between 180 to I think about 500 ...over that its more likely to be a #$%$ FH diagnosis
The drug will be expensive ..sub Q injection either every 2 or 4 weeks ...it won't be damaging to Anchor , Reduce it
JMO ( I have hetero FH and a Cardiologist and I did discuss my participating in Amgens trial ...but I dont like needles and would rather try and get my lipids in line with max dose Crestor and max dose Vascepa )
From HDGator on Ihub
Epanova increased LDL 15% relative to placebo and 26% relative to baseline arm
Amarin's patent is written to cover both placebo and baseline ....thus they infringe .
So unless they reformulate they may need Amarins patent to combine with Crestor
I'm not Williams but the following info might help
AZN is claiming that Omethera does not infringe on Amarins patent that covers an up to 20% raise in LDL on treatment .
AZN claims that since Omethera increases LDL by about 20.5 % compared to baseline or placebo ( sorry forgot which one ) they dont infringe and thus can combine with Crestor if they wanted to
However ..when compared to baseline or placebo ( forgot which one ) Omthera only raises LDL by about 16% ...thus would infringe on Amarins patent .
Amarins patent is written to cover change from both placebo or baseline ...change has to be greater then 20% not to infringe
It 88% EPA ...regulated by the FDA as a food ...not as a drug ...if you CAN NOT get V with insurance coverage or otherwise afford it ....it's worth considering .
I have used it , but prefer , and can pay for , Vascepa
Suspect they will push the 2gm version as an add on to Statins as a low cost way to reduce CV risk
" reduced my position " ....say it ain't so .
The run up today was because of the court docs filed by AZN in their effort to
launch Epanova ....looks to me that they are in trouble as they infringe on Amarins patents for lowering TG's without raising LDL by more then 20 %
Right now they (AZN) seem to be trying to steam roller over AMRN , but I don't think it will work unless they can find a flaw in Amarins patent.
The main act ...FDA decision , is yet to occur ....I rate it at 70/30 in favor of Amarin ....so I'm not selling
But if you already have a profit ....well done
Re CV risk. You state "all the science in the world pts to LDL decrease and HDL increase "
THAT was the majority view until the NEJM articles on the role of TG's and APOC3 a month or so ago .
I wrote a post on it in case you want to search back
Yes , the primary focus is still on lowering LDL if it's elevated and you have known risk factors BUT raising HDL is not considered as important . Low HDL is now seen as related to CV risk but not causal.
Elevated TG's and APOC3 are however now seen as being more causal .....so the science has shifted and I think Dr Jenkins will reflect that in his opinion.
Note ..I'm giving a brief over view ..so not mentioning Jelis and recent EPA research etc
Dr Jenkins is buying time only to formulate a response to the Citizen Petitions and to write a thoroughly
researched and well argued opinion ....which I believe will be a reversal of the existing opinion which is that there is no benefit to lowering high TG's
Why approve now ....about 600,000 people die each year in the US from a heart attack ...If allowing wider use of Vascepa only reduces that by 2% ...you have saved 12,000 families from losing some one to heart attack or stroke
There is a risk to not allowing wider use of a safe drug that increasingly looks likely to show benefit
My guess is that we are back to $1.20 if the FDA completely shuts out Anchor or expanding the label
If we haven't made a dent into the Marine indication by now ,IMHO it's not going to happen ....Marine is about pancreatitis risk , Anchor is about CV risk . Anchor is where the $ are
Re options ....best to ask Cro ...he has forgotten more on option strategies then I will ever know ...I do own Sept 20 calls tho ....so giddy up FDA
My understanding per the recent CC ...was that they were renewing an old Shelf filing that had expired .
Either way ..expect Co to wait for FDA decision ( hopefully by mid Sept ) ...before they do anything ....and only then possibly , if the stock spikes on good news
If FDA expands the Vascepa label and if scripts triple by year end ( ie FDA says to prescribe to diabetics for example ) then they may have little need to dilute .
Yes I know...a lot of if's in there :)
Actually Den whats interesting to me is AZN's Omethera .
I think GSK is heading in other directions biz wise.
Re AZN and Omethera
They claim the composition is 15-25% DHA which would infringe on Amarins patents of less the 20% DHA in possible Vascepa formulas..
Has the launch of Omthera been delayed until this is worked out
Any news ?
In the CC they stated mid Sept
Is the delay good or bad ? IMHO its more good then bad because it gives Dr Jenkins and the FDA council thats being conviened , more time to go over in depth , all the recent research on the role that TG's in the 200-500 range, play in CV disease .
Particularly the recent NEJM articles /research
Also ...decisions to reverse policy usually take more time to formulate and defend then decisions to maintain the status quo
JMO ....no guarantee's ..only risk what you can afford to lose.
This is somewhat OT and I reminding you of the obvious
Small Cap biotech in general is a very risky investment no matter which co you invest in .
For every 1 major win there are probably at least 5 losers .
As a rule of thumb I stop myself out of at least half my position if it drops 15%....and re evaluate.
Most of my $ are in the IBB etf and GILD ....ie big cap biotech
With AMRN , the preponderance of recent research supports the FDA at least granting a wider label for Vascepa which if it happens will propel the stock higher . Following that will be the risk of dilution and marketing challenges .
My best case scenario is a repeat ( % wise ) of the initial market reaction when the Anchor trial results came in .
Best of luck to you