Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I would add to that the biggest fear is profitability and Sales.
WS was heavy into a BO or a partnership and severely unhappy with GIA strategy. So now it's a question of sales. Initial consensus earnings for 2013 were 90 million, it's now half that and with the coupons even with the current scripts they are unlikely to reach those estimates so estimates will be coming down for 2013 after the next Q.
Then the question turns to 2014. What sales can thy expect? Since WS thought they'd get 90 million and they got 30 million in 2013 means WS has low expectations for ramp up of Anchor sales. They probably need 25K weekly scripts to talk about break even and they are at 6K. Average 2014 estimates are 210 million sales and 69 cents a share loss.
So at what point do they have a profit and how much, if WS is correct 2015 equals 365 million sales and about 30-40 cents earnings for the year, at a P/E of 20 for growth prospects you get $6-8.
So it's a simple case of prove you can sell 1 billion a year of the drug quicker than WS estimates. Start showing sales above estimates. If they start doing that institutions will get in.
If they get Anchor AND partner WS will believe they will get there faster and would drive the price up at least double from here...GIA for Anchor I think WS will wait and see until mid-2014 and see if company comes through on sales. Thus $6-8 will hold for awhile.
They execute sales and price will rise, how fast they execute sales determines how fast it will rise. Simple as that. Right now WS has no reason to believe they will be profitable until 2015 so no reason to be buying the stock as an institutional investor.
This is why I continue to sell OTM Puts and Calls and hold my core position. Not much downside from here and protected to upside with core position.
Found this on Adcomm's from raps.org website:
In addition, it remains to be seen if FDA's advisory committees—essential for the review of new molecular entities and high-risk medical devices—would be convened according to schedule, or if they would be postponed. Advisory committee members are technically "special government employees," and might not be seen as "essential" under the law.
And then this note from Fierce Biotech:
"Of course, the scope of the word "limited" remains unexplained, and the agency isn't in a position to be terribly specific about where advisory committees fit in. "Generally speaking, these meetings would continue in some way," an FDA spokesperson said in an email to FierceBiotech on Monda
So I think its unclear on Adcomm's though many PDUFA require Adcomm's so perhaps they are funded similarly with fees and the FDA spokesperson saying they will CONTINUE IN SOME WAY seems to indicate AMRN is all set but what does "some way" mean? By conference call instead of paying to fly people in etc...? Couldn't AMRN offer to pick up the cost of the Adcomm as a user fee if it came to that? Seems based on FDA email Adcomm will go on and PDUFA is 100% clear will go on.
Per FDA looks like they will be going forward with PDUFA, still not 100% clear on Adcomm based on this info but others seem to be reporting Adcom will go on also.
10/1/2013]
Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.
99.9999%, I would say 100 but nothing is 100 so let's just say a positive vote will happen barring an act of God. 70 percent is absurdly low.
There will be zero votes against as it will be unanimous since there is not one reason to vote against. Logic tells me with zero reasons available to vote against it means they will vote for.
You are better off asking if the vote will be unanimous rather than pass and fail though the odds of unanimous approval is rather high also but slightly less than approval odds
Right but you need to add Vascepa sales to Lovaza sales to get a comparable number and that number is not far from previous Lovaza numbers
Niaspan had the bad study that came out and if you look at the numbers Vascepa plus Lovaza is pretty comparable to many weeks so it seems the only material drop is in Niaspan.
Niaspin want generic this week so assuming the numbers do not count generic the # should start dropping rapidly but in terms of fish oil prescriptions just seems like Lovaza is dropping and Vascepa is gaining, some weeks you can compare its not as noticeable but the overall trend that is clearly what's happening.
Anchor approval odds are extremely high, nobody has come up with a plausible scenario for denial and we are a few weeks from Adcom so yeah I'm assuming that 99% chance of approval since there is historical FDA history of that. Not one FDA denial has been shown with SPA in place , all end points met and no new information regards to safety.
Even though the Stock price does not reflect it the company is now in the best position it has been in in its history.
Prescriptions are accelerating, took 8 weeks to go from 4K to 5K weekly and 6 weeks to go from 5K to 6K
Cash, thanks to influx from dilution is in a good position.
Less than 3 weeks to Adcom, less then 3 months to expanded indication. Less than 4 months to 1 year since initial launch which should increase tier 2 coverage and some doctor's willingness to prescribe.
The biggest take is the incremental increase in script growth.
Would expect large percent revenue growth in 2014, due to coupons expiring, tier 2 increasing and Anchor market we should see a rapid $ figure increase even with a steady script number increase in 2014.
The company is in a great spot right now and I believe at some point soon WS will wake up and realize it, I think it will be impossible for them to ignore the strides over the next 3-4 months
That AF logic, always a hoot. This comment alone has no bearing on Vascepa
"is a lot of clinical evidence presented to date suggesting the answer is no, omega 3s don't reduce heart attacks, strokes, CV-related deaths, etc"
but the reality is there is zero clinical evidence on pure EPA that has that conclusion. The clinical evidence on pure EPA that has been done shows it DOES reduce heart events. So his theory is basically the same as saying ibuprofen does not prevent something so aspirin should not be used for that something.
It's incredibly flawed logic but it does point to the large uninformed population of doctors and primary care physicians that think Vascepa and any fish oil study have a correlation.
Considering statins do 20 billion dollars in sales yet PEOPLE ON STATINS DO NOT LIVE ANY LONGER THAN PROPLE NOT ON STATINS. So let's not act like the FDA has a giant standard of proof to approve cholesterol lowering drugs. Vascepa is safe, no side effects to speak of, how would the FDA look if Vascepa prevents heart attacks and extends lives and several people die the next few years because they did not approve a drug with zero side effects and meets all endpoints and was designed with FDA approval.
AF has an agenda, simple as that, he has zero facts to support his case and tries to lump Vascepa in with studies that never use Vascepa to try to make a poor point. Sorry, does not fly.
I think Omthera has a pretty easy approval for High Trigs, it would need to be worse than Lovaza in some areas to get denied.
I find it interesting they are planning to conduct a large scale cardiovascular outcomes trial for Epanova with Statins since they have not started and are now 2 years behind Vascepa. Even if they somehow have success, that means Vascepa already had success and would be over 2 years ahead in the market. Nobody would buy Epanova. If Reduce It failed then AZN would have 2-3 more years to complete their trial which would be expected to fail.
Seems like AZN is oblivious to reality in the fish oil sector, they just plod along with Epanova like it's some new drug in the sector. They have little chance of Anchor approval, they haven't even started to apply for that area so in the areas where it could ever make money they face a superior product that has several years head start in a market they may never even be approved for.
I like how they throw this into the Reduce IT press release..
"An SPA agreement is generally considered binding upon the FDA unless public health concerns unrecognized at the time of protocol assessment are evident."
So why is it they could back out of Anchor approval?
Though I'm also not 100% convinced WS thinks Anchor has any chance of denial, sure minor overhang but think WS is more concerned with how AMRN will s ell Anchor, partner or dilution and GIA? So in the long run I expect they can get sales to a profitable level, I do believe the biggest overhang is lack of clarification for Anchor launch, not actual Anchor approval.
Then the overhang if GIA will be how are they going to raise money GIA to launch.
It's down today because Adam F tweeted indicating if there is a government shutdown they may cancel all Adcom's...Is actual tweet was
FDA is referring all ?s regarding potential gov't shutdown and potential for canceled/postponed adcomms to OMB
but the insinuation for AMRN is Adcom would be cancelled and thus Approval date would be pushed back.
Now this is under the assumption that at the last hour the Republicans don't back down from "de-funding Obamacare or shut down the government" position which they've backed down from every other time, especially when many Republicans do not agree with the position this time.
I suspect they will extend government funding at the last minute and Adcom will go on as scheduled. But this adds more fear to a stock with a decent short interest and thus the loss today, if they get to Adcom it will recover but with 2 weeks until congress gets things done the run to Adcom will be delayed until very near the Adcom.
What insurance do you have?
Or there is a number 3 that involves them just not making a decision until 5 years is up, perhaps they had decided to grant NCE with the letter that was circulating and there were lawsuit issues so they just decided they will sit on the decision and de facto grant NCE without ever granting it.
Or there is the number 4 related to the citizens petition on Lovaza needing to be finalized(though that was not even filed until 6 months after Vascepa approval so why the 6 month delay then?)
I see your points but Anchor has zero relation to NCE, there is nothing in NCE guidelines that would make Anchor have anything to do with NCE-the drug is not changing at all and NCE is solely about the drug and whether or not it is a new chemical entity, yes or no on Anchor has zero bearing on that. It's possible someone at the FDA said, I feel better defending a lawsuit IF Anchor is approved as we can argue it is clearly different from Lovaza in makeup proven by the different results but even then the results are already known so approving Anchor changes nothing in regards to what Vascepa does and is. it's very hard to come up with any logic based on facts where Anchor approval had any bearing on NCE.
At least FDA guidelines specifically say there should be an Adcom for any NCE possible drug, it doesn't even clearly state what the Adcom needs to be about so it is all rather vague.
It seems every past speculation as to what they are waiting for has been wrong and despite all we speculate, in the end, its probably something never mentioned by any of us.
Since it seems NCE designation requires an Adcom or a reason why there was no Adcom I cannot imagine there would be an NCE designation until after the coming Adcom. I guess if it comes up during that we will know it was waiting for that. If it never comes up in the meeting then it may be a case FDA will not decide until 5 years is up as I can see no other reason why a delay outside of the Adcom requirement.
5830 scripts if updated spreadsheet is accurate-Better than 5600-5700 expected based on week after July 4th week
That's interesting math but it's better to use income expenses, sales estimates etc...
The sales figures you talk about are only reasonable with Reduce It Success which is several years away and unknown results at this time.
They need over 20K weekly scripts to break even-lets concentrate on a time frame for that to happen.
Marine should be doing 13K by end of 2014 assuming no major setbacks due to generic Lovaza or Omthera competition(which I personally think will not be a issue) and assuming the current pace of script growth stays the same. Lots of assumptions but nothing else we can do.
It will likely take a full year to get Marine to 7,000 scripts so we can assume Anchor should at least match Marine and get to 7,000 scripts weekly by end 2014 so worst case SHOULD be Q1 2015 profitability with GIA scenario.
You'd expect better Anchor sales than marine due to larger market but don't really know what that multiple should be, On the flip side you have 2014 ending discounts and coupons and if Tier 2 is not widespread you may lose some scripts due to cost. The again, Tier 2 should expand greatly after 1 year in the market so scripts could accelerate in 2014.
So I think we can safely say break even in Q1 2015 and we MIGHT sneak out 3Q or 4Q 2014 with a profit if Anchor sales accelerate faster than marine. Of course we have much higher interest payments starting in 2014 but still think 20K plus weekly scripts gets them close.
I would assume it is because it was a Phase 1 trial and the goal was not results but bio availability, I think they have published various results with Vasceopa and Statins, I don't think it's a case of being mum but the Phase 1 goal was just different.
I think you overestimate the sales forces ability to sell and inferior drug in a market already established with competitors. I'm not even sure they will make much effort, I think this is just a first step towards a combo drug for them and,again, pretty sure the Marine market is much smaller than estimates and Vascepa sales will mainly be in Anchor-where the bulk of sales for Lovaza currently are at and where Lovaza and Epanova will be uncovered by insurance..
I've been on board with partner vs GIA on Anchor, of course forever sub $10 would not be longer than 2018 as Reduce It will be everything. Positive Reduce It stock would be 100, negative would be a stock killer.
But I agree a non-partner Anchor launch could keep the stock price sub 10 for awhile unless they can prove they can sell the drug and get sales while a BP partner puts it above 10 easy right away assuming it is a reasonable deal.
Epanova a little late to the party, Anchor will be well established and as we have seen with Vascepa failing to take away Lovaza market share in droves once people are on something working they don't switch easily.
Again, seems like Vascepa has timed entry to market pretty well and by time any competitor gets to have a sniff of entering Anchor market Reduce It will be out ending all discussion on which drug to prescribe if positive result.
Just don't see Epanova as a material competitor to Vascepa
I think the problem is there is a wide range of sales estimates, even for 2013 originally consensus was near 100 million and now it's half that. One of the easy ways to picks stocks is when you have analysts sales revisions upward by a good % the stock is going to go up and one way to find stocks to sell is find analysts estimates that regularly go down a good %.
If they GIA on Anchor WS is going to believe they will fail to get good sales in 2014 so the stock will not gain based on 1 billion peak sales or anything close. Consensus will be 200-300 which at biotech multiples is about where we are now. The stock will not go up until they announce 2014 Q #'s and prove they can sell the drug without a partner, simple as that.
That biotech's can have a market cap related to future sales estimates is true but AMRN is not going to be based on any future sales since WS believes no partner equals low sales until AMRN prove otherwise.
I find it extremely telling that the one analysts that gives sales figures with or without a partner gives a 100% increase in sales with a BP partner.
If they partner correctly stock goes to 15 within a few months of partner deal and is sold to partner for 25-30 within 12 months
They don't partner and we will not see above 10 until second half 2014 and we will only see it then if sales are good, otherwise we could see more dilution and a wait until sales start exceeding WS #'s or Reduce It to see 25-30.
Is there any real catalyst outside of sales? I do wonder how much bump there will be upon Anchor approval, On one hand It seems to me there is an overhang on the uncertainty of Anchor approval, on the other hand anyone with common sense and the ability to analyze reasonably well can determine the odds are extremely high for Anchor approval, so high I can't imagine anyone would put up money to bet against it.
However, based on the drop related to the Lovaza generic fear I wonder how much the stock will move once Anchor is approved. It seems WS questions whether Vascepa will sell and make money more than fearing Anchor approval.
Imagine JZ announces we are not partnering for Anchor...won't WS sell off on that..? Will that make up for the Anchor approval pop...? Thus we will still be selling below 10, and perhaps in this same area even after approval..?
Just wondering aloud if there will be much movement without a partner, that WS will not invest in AMRN without a partner unless there are actual sales that shows the BB potential is not just potential but likely...obviously 30-40 million in first years sales is not giving WS that impression.
If that's the case we probably have a wait until mid-2014 to see what sales are like before we get rewarded. Assuming they can get a proper selling force together for Anchor. BIG decision for JZ coming on Anchor launch.
Excellent overview, hopefully this knowledge becomes common knowledge at some point. It amazes me with the numerous studies showing EPA benefits vs DHA that the common thought by people is fish oil is fish oil. I suspect this may not change until Reduce It but it is sad that science gets ignored in favor of headlines when it comes to fish oil and EPA/DHA.
Any reals studies that show at what level EPA intake, in a mostly healthy person, is beneficial over the long term? Say your in your 40's, low trigs, exercise, OK diet but would like to prevent future issues as you get older...Is half the Vascepa dosage enough to be worthwhile or do you really need the full 4 to get real benefit?
I'd say the fact it included a holiday week is the main reason that happened. New scripts require doctor offices to be open while refills do not. Still a good sign refills were up on a holiday week
I would say it still needs a Phase 3 and then FDA approval which likely puts it near REDUCE IT results time.(Within a year at least) Besides the fact they don;t have results to compare to Anchor or Marine yet.
I don't think there is any drug in testing that will be approved for Anchor population far enough ahead of Reduce It to make any dent in AMRN sales and none of those possible competitor drugs have even started a Reduce It trial. Since its expensive and 5-6 years to run AMRN is likely assured 5-6 years of Reduce IT related monopoly.
Even IF another drug comes along with better Trig and cholesterol details, IF Reduce It is successful Vascepa will lose almost no sales to that new drug.
If Reduce It Proves it reduces heart events, the other drugs will not have that proof. Doctors will prescribe the drug with an outcome study.
So I find little to be concerned in regard to ANY competition since Reduce It results will be known before anyone can really sell there product.
If Reduce It hits-Jackpot
If it fails-Disaster.
Anchor will be AMRN's territory alone for several years.
That's pretty much it.
Solid scripts at 5139 but trend analysis will be better to see next weeks numbers that don't have a holiday in it. Using July 4 week as a guide should see 5600-5700 next week, better is a sign trend could be improving so hope for better but expecting 5600-5700.
Solid numbers for a short week,seems about right on expected number or ever so slightly over.
Seems we are getting to another 1,000 level every 2 month-4000 crossed in June, 5,000 crossed August and on pace for 6,000 cross in October, if trend in marine holds through next year should have 92 million in Marine sales alone in 2014.
Apparently the FDA likes to change their mind, I have an email from them last year stating holidays didn't matter in regards to full work week and OB update BUT I have email from them today stating OB date is next Friday due to not being a full week so they changed their minds in the last year or the guy this year is unaware of what they did in the past. We have had two examples I've seen where there was a holiday in the first 2 full weeks and both times OB updated as if the holiday was not a factor. Today they say holiday is a factor. Mind blowing.
So, who knows with FDA..t
Interesting note:
"Express Scripts, for instance, requires so-called step therapy – patients must first use other therapies that have failed before the pharmacy benefits manager will approve Vascepa for treatment"
I wonder if this changes with an Anchor approval. Reduce It would obviously change that.
If they partner, they win, if GIA, it's a struggle big time, simple as that.
A BP partner will get insurance changes quicker, will have the sales force etc...Nothing more important than getting insurance to restrict Lovaza prescriptions. Now if you order Vascepa many insurance companies suggest you should look at the cheaper Lovaza, that would be more prominent if generic of Lovaza is there as even cheaper. A BP will have better access to insurance to
1)Make Lovaza and generic un-prescribe-able for Anchor
2)Make Vascepa, due to better safety profile-the preferred choice in marine
AMRN's success doing those things alone are less than if they can partner with BP.
Summer Street came out with note today, first analyst to say they thing they will not be approved for Anchor, which is based on the lack of outcome trial which is not a reason to deny anchor so seems Summer Street is on the short side.
If JZ does not partner then he is planning to hold on until Reduce IT---not sure i like that strategy.
"Will mean next week is the second full work week! " IS INACCURATE.
Holidays are meaningless with OB schedule. We've been watching this for over a year, trust me, I know for a fact the FDA schedule for OB update is Sept. 13.
Whether they make the goal is another story but they consider the second full week Friday as September 13. They ignore holidays and consider full work weeks to mean they exclude weekends, only weekends, they never, ever exclude weekdays so if it's Monday to Friday then it's a week regardless of holidays.
It was updated September 14 last year FYI. Last I checked there was still a Labor Day last year.
I am 100% certain on this. can you get more than 100% then I am also that!
I can forward emails from FDA that state this if anyone really doubts it but I can't believe after 14 whatever months this is ever questioned anymore. It's just a FACT.
FDA has been pretty reliable on time frame, it's been as early as the Wednesday before and as late as the Monday after the second Friday except last month when they had a computer glitch causing the week delay.
Assuming there is no continued fall out from the glitch I see no reason why it won't be updated in the regular time frame between now and Monday.
I wholly expect no decision until after Adcom anyways but we will see soon enough.
Seems initial comments I read on patents was not totally accurate once details were out so main reason for drop is either, mis-information on AMRN patent protection or 100% related to fear generics will take main market share and Lovaza and Vascepa will be left with scraps.
Not concerned with that,Pretty clear to me that Marine market is lower than everyone estimated, If Teva thinks they are entering a 1 billion dollar market with a generic they will be sorely mistaken as I'm convinced Lovaza does 70% of sales in Anchor population.
Of course On the initial look nothing positive about having generic Lovaza to compete against us accept GHK perhaps pursuing AMRN and GSK not spending any advertising dollars or efforts on Lovaza. By time Teva gets a ruling, courts finalize everything, Teva moves to production and selling AMRN should be near Anchor approval and sales anyways. I don't call it a non-event or positive but not a 8-10% drop event for sure.
The reality is Anchor market by itself is worth a 5 billion market cap and AMRN will have that to itself soon enough.
Partnership should be the #1 option, by FAR, for Anchor. They get a partner for Anchor we will be 15 or so heading into new year, they don't and us holders will be waiting until Q 2 2014 sales to make much hay.
It's second full week which is THIS Friday. As clearly defined in the past full week means Monday thru Friday is a full week and second full week is clearly the 13th which is in 2 days.
Labor Day does not matter if that's what you were thinking, Holidays do not negate a full work week.
It might move up generic timeline but definitely makes it more likely. It has to go back to a lower court to have a new ruling. However, there are higher courts that can be appealed to so this could drag out, really hard to say not knowing what Pronova wants to do.
The longer it is that it takes generics to come on the larger marine market share AMRN can more easily attain and easier for them to keep that market.
This patent loss by Pronova is exactly why WS still puts value on NCE-which next update could be 2 days from now.
Yes and no, assuming Vascepa gets Anchor indication that is highly accurate but in the here and now Vascepa has had a hard time gaining share quickly and cost is a large factor as you can see the heavy rebates and coupons, etc... So a generic version of Lovaza is even cheaper than Lovaza tier 2.
The concern over whether AMRN's patents can hold up is also out there since Pronova's patents cannot hold up. of course, AMRN will have 40 patents and Pronova is basically trying to defend 1 patent so not as concerned on that.
On the positives
1)Generics can't sell to Anchor, which is the main market
2)Lovaza has side effects
3)GSK may want to pony up a BO of AMRN to replace accelerated Lovaza sales losses.
28% profit for anyone that got in on recent the secondary, not bad for less than a month. I wonder at what point some of those people sell for profit?
I noticed 20,000 in volume on October 10 and October 12 Calls. Cannot tell buy or sell but seems it could be a buy of the 10's and a sell of the 12's as that logically makes sense which mean someone looking for stock to be mid-10's after Adcom.
It could be the other way around in selling the 10's for profit and buying the 12's to have a maximize downside but logically the first scenario makes much more sense for an option player. That's a likely 540K+ wager it's mid-10's by then if so.
There are also Jan 12's near 20K in volume which could factor into the equation as well.
We've seen these heavy bets before during AMRN BO fever and they were all losing bets but always good to see big money looking for upside.
Thanks for posting, again confirms to me partner should be done even with giving up more than JZ wants.
2 billion in sales with partner vs. 1 billion in sales without partner. That says it all.
They sell 50% and they get money to pay off debt and avoid future dilution and also going forward reduce expenses and still have the the SAME amount of revenue as GIA.
They can always build in a change to the percent share of sales if REDUCE IT meets endpoints, otherwise, up to reduce it, there really is very little reason for GIA.
Approved July 25, 2013 and NCE the next month. Does make you wonder the back story on AMRN and FDA regarding NCE.
Either FDA will not decide on NCE until 5 years has passed and then deny or they are waiting for the Adcom since NCE requires and Adcom or a reason no Adcom was done.
Does not seem to be any other reason that sounds plausible for such a long delay when they can make the decision on another drug in mere weeks.
Not sure how you figure? Based on Open Interest?
Options pretty much come into play if it is near a strike price heading into the last few days before expiry. Otherwise, the effect they have on the stock the rest of the time is minimal.
The MM's in the options hedge against the positions but MM's also like to maximize the options that expire without conversion.
The 6's are even on Puts and Calls so MM;s don't care about 6's.
The Sept 7's have 9.5 times the Put OI so if it is near 7 at expiration they will try to peg it just under or on to avoid converting all that stock. This is very likely as there is no news expected until Adcom barring surprise NCE decision before Adcom.
So, barring news, which trumps all, the options suggest MM's will let the trend continue and if the trend brings it to 7, they will hold it down just under 7 until after September 20 but, again, they hedge positions so if there is news or strong buying moves it past 7 options will hve little bearing on the stock price.
October has huge call OI in the 6's and 7's and high Put OI at the 5 so clearly lots of hedging going on for the Adcom. MM''s have already put themselves in position to win/win so despite the large $6 call OI it would not come into play unless Stock was near 6 at expiry.
I agree, tier 2 is big, I think it's great they get a full year in the smaller Marine market so they can hit the ground running in Anchor market with, hopefully, a very high percentage of tier 2 coverage.
They have a ton going for them in Anchor launch, still want a partner to ramp up sales quickly, they need to be in the low 20's to turn around cash burn and think that would be a lower number if partner takes on some of the expenses and would be within reach really quickly. Once cash burn becomes cash flow all of the short term question marks go away.
"When I picked up my Vascepa there was no checking to see if it was off label or not "
That whole quote was what I was missing, I was under the assumption you had to have the doctor say you had trigs over a certain amount to get covered, that they would have some kind of check on that but since it is not the case as long as you can get the doc to write the script, insurance will assume you are on label not off