And someone said it before but I do spell "Vascepa" incorrectly several times, but with my excitement and 3AM rambling, I don't care to spell check and make sure I crossed my T's and dotted my I's.
I feel like this drug is so much more than what we are really prescribing patients with it for. It is something everyone should take, it's a pure form of EPA fish oil. It would take approximately 20-40 pills of fish oil to get the recommended dose of Vaspeca. Fish oil pills also contain other omega's that don't give you the benefit pure EPA does.
As an athlete I took fish oil for years and still do. Several of my fit friends who i played collegiate sports sweared by it, stating at high doses it increased recovery rate, decreased inflammation, along with increased muscle mass and decreased fat due to increase of metabolism. I myself have felt the affects of taking high doses of Arctic fish oil. I am still only getting about half the amount of EPA I would from a single dose of
I got a stock tip about AMRN about 6 months ago and did my DD and really thought Vaspeca had so much more to offer and at some point could very well be prescribed to the masses for everyday health. That making me and everyone that owns stock filthy rich :)
hey staccani i appreciated ur calculation could you pleasr make simple for me to understand how to calcumte market cap and shares price? bc i alway wonder what make it actual shares price? answer is bc shares are depending on ppl trade it.
Connecting the dots:
The Oct 16 EMDAC Meeting was specifically set up for "rationalizing" SPA rescission on Oct 29 (however, what a mess!). Nov 22 refusal was FDA's defensive move (trying to limit the influences), and Dec 16 JZ resignation was AMRN's offensive move (getting "lean" in dealing with FDA). The fraudulent "sciences" employed by the reviewing division made the division losing all credibilities. Originally, Dec 20 was set up as ANCHOR PDUFA. However, the action was focusing on SPA, and no new PDUFA. Dec 20 action should have been decided by FDA's higher level. Now, the probability of re-instating ANCHOR SPA on Jan 15 is greater than 50% and ANCHOR approval will be a natural extrapolation of re-instated SPA -- no new PDUFA is needed.
I had a chance to discuss this with a friend who is a Prof ( PHD / scientist ) at UCSF . He also thinks that higher ups at the FDA are questioning the basis of the decision rendered by the lower review board.
He is not making a judgement on whether they will reverse ....simply saying that appears the lower SPA review board over stepped and should not have extrapolated (. Ie. because no benefit from Niacin there will be no benefit from Vascepa )
The only reason to post on this board to to test a thesis .
I welcome informed arguments on why the FDA will NOT reverse their stance
I have no proof ...I am merely speculating .
I have read the FDA articles on SPA's and the basis for rescinding an SPA and suggest you do also .
There are central legal points here.
The 2 pts are risk to public health and evidence coming to light that shows there will be no benefit .
First ...Vascepa does not pose a risk to public health
Second ....has evidence come to light that shows no benefit .
The SPA review board decided based on the Aim High and Accord trial that there was no benefit to lowering TG's .
They made this judgement even tho most in those trials had normal TG levels.
So the question is ....can you extrapolate and expect the same no benefit results based on a totally different mechanism of action at higher doses ( relative to TG effect ) in patients with far higher TG levels .
I don't think you can ....which is why higher ups at the FDA delayed the decision and are reviewing this .
That's just my take
I welcome all informed counter arguments
In my experience Cardiologists will treat TG levels above 400 without question ( I 'm speaking for the 4 Cardiologists I know ...all treat TG 's over 400 )
After that their attitudes separate depending on whether you have other risk factors like family history , high LDL cholesterol or HDL cholesterol below 40.
Even when you present with all the risk factors mentioned above ...there is no consensus
Some work off EBM ...evidence based medicine ....others work off association and possible causation and others work off " well it ( Vascepa ) may help you , certainly won't hurt you "
The central question they are all wrestling with right now is " Is there anything other then Statin drugs that reduce CVE ,,,cardiovascular events "
Joe Z gone is of no concern to the FDA
For the record ...I am glad Joe Z is gone ....anyone that tells Bloomberg that he will only take $30 a share or higher for the company , and then sells his own shares for around $12 each .....after accelerating the date at which his options would vest ...is not someone I want anywhere near my investments .
Frankly I hope his retirement is filled with an endless number of lawsuits as investors try and claw back some of his gains.
Re the FDA ...there are certain legal conditions to be met before they can rescind an SPA . I think the higher ups at the FDA , particularly their legal dept are looking to see if they have just cause to support the action that the lower SPA review board took
The SPA appears to have been rescinded on the basis of the Aim High and Accord trials .
This will be open to challenge because these trials did not have patients with high TG's nor where they using high doses of EPA.
Simply because benefit was not seen with Niacin on patients with average TG levels ....you can not extrapolate the same results for patients with high TG's on high doses of EPA.
That is what the FDA 's legal dept is looking at IMHO
To counter a recent Fool article ....There are over 600,000 deaths per year in the USA I believe from heart attacks .
If Vascepa is successful in reducing that by only 5% you have saved 30,000 people in any one year .
If Vascepa has no effect ....the same number die of heart attacks .
There is no downside to making Vascepa more available to those at risk beyond the cost of the drug .
If the FDA refuses to expand use of the drug ....and the Reduce it trial comes back showing clinical benefit ...I would not want to be the FDA official who refused to allow wider use .
Did you have any proof of your post or you're just speculating? If true, that will catapult the stock to previous level before the implosion.
Why FDA delayed ?
IMHO ...actions by Amarin and the Epadruginitiative groups CItizens Petition prompted higher ups at the FDA to reconsider .
Note ...PDUFA Reauthorization . Performance goals and procedures fiscal yr 2013 -2017
Section V11. #5
" Agency will not alter ....etc ...unless public health concerns unrecognized at the time ..etc ...under this process are evident "
The FDA has not identified any health concerns with Vascepa .
The Adcom for Vascepa was supposed to be about whether Vascepa taken with a Statin could lower TG's without raising LDL cholesterol.....the Anchor indication .
It was not supposed to be about whether or not Vascepa reduced heart attacks ...the Reduce it indication.
Instead , Dr Coleman representing the FDA over stepped his mandate IMHO and extrapolated the results of the ACCORD and AIM HIGH trials in a way that was completing inappropriate.
Thanks to Amarin and the Epadruginitiative group ...higher ups at FDA are now well aware of this situation and IMHO are likely to reinstate the SPA.
JMO ....do your own DD ....not recommending anyone buy or sell ...this is a highly speculative situation
What are you talking about?? I ask for people's opinions (received 6 great responses) and this moron calls me a buffone for asking the question, so call him a moron in response and question his sanity, and I'm wrong? You must have been taught to turn another cheek.
Long didn't sound near as rude as your response. You certainly did not sound Rational. If you want feedback, listen and use it, or not but do not go off the wall with your dissatisfaction. You are incapable of discussing things without verbal flatulence? Or were you setting up for personal attacks to use in your bashing? You may get iggied here if you cannot be real.