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I Googled it, says exactly what I stated already. People that think that if a stock falls below $5 means institutional investors have to sell are just wrong.
Many cannot trade OTC and pink slips but very few have restrictions on under $5 and even less have absolutes on under $5.
Margin requirements are different for stocks under $5 so there is pressure there, you can't list oginally for less than $5
The official SEC definition of a "penny stock" is an equity trading for less than $5 a share that is not traded on the listed markets of the NYSE, Amex, or Nasdaq, but on the bulletin board or the pink sheet
Mutual funds draft their own charters, and some choose to avoid stocks under $5 a share. However, they are not obligated to do so, except for fiduciary reasons. Many mutual funds specify that they will hold only stocks listed on the NYSE or the Nasdaq National Market. Furthermore, unless the fund explicitly specializes in small-cap/high-risk shares, holding penny stocks may be bad for business because they are perceived as an unwarranted financial risk for investors.
And on a positive note
It is more difficult to short stocks trading below $5 a share, since price is one of the factors the SEC uses to determine a stock's riskiness. As a rule of thumb — though this is just one criterion — stocks trading below $5 are "not marginable" and therefore not eligible to borrow or sell short.
Can you point to prospectus that have that? I just checked several of the biggest funds and not in there so please point me to the large funds that have this in there, Thanks.
OK, are you living in some fantasy-land? Institutions can hold any stock they want, there are almost zero that forbid owning stocks under $5, there are a small percentage that have guidelines that say they won't but even those are just guidelines not hard rules.
Market cap is more important than stock price FYI.
Just check SIRI and the institutional holders, SIRI has not been over $4 in over 10 years yet Vanguard owns 139 million shares, 61% of the float are owned by funds and institutions.
I continued to be amazed at the ignorance of people that actually believe things because they heard it somewhere.
A drop below $5 does not cause mutual funds and institutions to sell. Sorry, just not a fact. Traders may be more active around $5 and thus more volatility but mutual funds and institutions can hold to 10 cents like they did with SIRI a few years ago.
It's not logical that a stock that has gone steadily from 15 to 5 has much left in accounts that is being held in margin.
The Main stock market is due for a ST correction(5% from recent high maybe) so expect August to be rough, but the market will turn sometime September/October and head higher again.
With market sentiment likely negative for August AMRN will have tough time moving forward without news of its own to push stock up. Earnings/scripts maybe....?
I'm getting closer to adding, sent the money I've been holding since December to my brokerage today. May wait for 2Q CC in early August to put into play but may sell some OTM PUTS before then, we shall see but bottom, if not now will be in within next 30-60 days barring large news events.
September to January should be the turning point for AMRN's trend.
AMRN to meet with Roth Capital per fly on the wall. Boy they meet with everyone, Citi, Jeffries, JPM, Roth Capital....
That JP Morgan report and post is fabulous. But they do not make any sense. They have 3Q earnings at 23% higher than 2Q earnings. Never mind the 6.5 million and the 8 million dollar #'s.
If you look at the first 2 weeks of 2Q and compare to first 2 weeks of Q3 the scripts are 114% higher. IF AMRN just maintains the 7/12 script #'s of 4507 for the remainder of the quarter scripts for 3Q will be up 39% from 2Q yet they show a 23% increase in sales?
But then they base price target on DCF which starts its calculation with sales and clearly how they arrive at the sales figures in the near term makes no sense, never mind as you get further out and have more unknowns so the DCF calculation is meaningless and flawed.
It's almost like they made no effort to come up with numbers. I know they just met with AMRN but they are 2 weeks from 2Q report, they couldn't wait until then to update their report?
This is not to say Reduce IT will only be statistically significant in unstable angina as you can see from JELIS the people with CAD history got more benefit than those that did not and as stated it would ave been interesting to follow up long term for mortality.
Reduce It has much sicker individuals than JELIS and thus we will more likely be able to see if the effects of EPA will reduce death and other events. I think it's possible if JELIS study continued and follow up at 10, 15 and 20 years we may have seen a statistically significant reduction in areas other than unstable angina. Hopefully, Reduce It will show this but it cannot be argued that JELIS, at study conclusion, reduced deaths from heart attacks because in Heart Attack and Fatal MI there was no difference in the groups. Then again there were so few of those events in total I just think the healthy population made it impossible for EPA to show any effects in that area as regardless of EPA people in that group were not going to die in any significant numbers within the period of the study. Hopefully this is something Reduce IT can prove with a sicker population.
The JELIS study had reductions in all areas but after adjustments the P values only showed that the Angina was proven to be statistically significant in the entire population. Even though there were reductions in other areas the P values were not statistically significant and in science p values is what matters. In the whole population there were no statistically significant differences except in Angina.
From study analysis at medscape
Among the primary endpoint components, a 24% reduction in unstable angina in the EPA group was the only significant difference compared with the control group.
Analysis of combined endpoints showed a significant 19% reduction in nonfatal coronary events, defined as nonfatal MI, unstable angina, or CABG/PCI, in the EPA group vs controls (P = .015). There was no significant difference in all-cause mortality between the 2 treatment groups.
When you break out the subgroups you see if you had no history of coronary artery disease:
In the 14,981 subjects with no history of coronary artery disease (CAD), major coronary events were reduced by 18% in the EPA group vs the controls, although this difference was not significant. Nonsignificant reductions were also seen in nonfatal MI, unstable angina, and CABG/PCI, and in combined endpoints of coronary death or MI, fatal or nonfatal MI, and nonfatal coronary events.
VS if you did:
Compared with the primary prevention subgroups, the 3664 subjects with a history of CAD tended to be on antiplatelet drugs, antihypertensive agents, and nitrates, and in these secondary prevention patients, EPA was associated with a significant 19% reduction in major coronary events compared with the control group (Table 3). Unstable angina was also significantly reduced in the EPA group, by 28%. Nonsignificant reductions were seen in fatal MI, nonfatal MI, and CABG/PCI and in combined endpoints.
After adjustment for age, gender, and prevention strategy, an inverse association was found between the risk of major coronary events and EPA/arachidonic acid ratio, suggesting that the effect of EPA may be antithrombotic or anti-inflammatory, or the effect may be such that it increases the stability of the atherosclerotic plaque, Prof. Yokoyama suggested.
AHA-designated discussant Beatriz L Rodriguez, MD, PhD (University of Hawaii, Honolulu), observed that although the overall reduction in major coronary events in JELIS was an "interesting" result, "there was no strong evidence that EPA affects mortality one way or another." It would be of great value, she suggested, for the study to continue the follow-up in order to reach an assessment of total mortality.
I completely agree but PCP's are not that detail oriented. The headline will be EPA prevents cardiac events if Reduce It is announced as successful. Some cardiologists and a few others will read the details and IF angina is the main reduction, as in JELIS, some won't recommend Vascepa but the vast majority, as is common, like headlines, and are swayed by headlines and will prescribe Vascepa for heart health.
Angina prevention does save money by preventing hospital visits and since it is a precursor to more severe heart disease you could logically conclude that long term it would prevent heart attacks, just maybe not short term. So prevention of Angina can not be dismissed as unimportant altogether either.
I'm just going off JELIS, the population for Anchor is more likely to show more serious problems are also reduced like heart attacks but my main point is due to the Angina being a primary endpoint figure, the odds of a disaster result from Reduce It is very small as worst case the trial should accomplish that.
Wouldn't that just indicate they do not have NME designation?
Which they do not because decision has not been made yet. I think it is an accurate answer, no Vascepa is not NME. I don't see any other meaning in there.
Would depend on the details. I believe the science indicates Reduce IT will be successful. Since Angina is on the list of endpoints I think its near impossible for it not to successfully meet that endpoint and thus call it a success.
Whether it effects the other endpoints is less clear to me though I think the science says it will. But it does not matter, It's overall events and overall, just solely on the Angina, it should be a success.
So with that thought I am likely to want to reap some reward when that hits and sales jump. Since the money tied up in AMRN is easy to hold long term I'd have no qualms with CVR if the terms were reasonable.
I believe that is in relation to draft guidance for generics. It seems AMRN wants the guidance to state it must be pure EPA, that anything else in it in more than trace amounts, DHA etc...makes it not generic Vascepa.
This is pretty smart obviously because it makes generics run right into AMRN's patent defense if they are unable to use more filler.
Though some of it can be used for NCE argument it's main arguments solely relate to trying to sway the FDA in terms of what they put out to generics.
Thus is the quandary they face. I'm pretty sure, based on information that has been out there, they were offered a partnership for Marine but was giving away too much so they said no.
Based on the JPM note that they are MORE likely to be open to partner for Anchor my guess is they believe they are in a better position to negotiate and can get a deal that may not be ideal but will be good for the company and shareholders. However, with being unable to get a partner for Marine on favorable terms I'm sure they are unsure whether Anchor partnership can get done so will pursue third party contract sales force if they have to.
Now for pure SPECULATION:
I believe partnering discussions have only gone slightly better for Anchor than for Marine. I believe management discussed with their advisers the issues they had getting a good partnership deal and I believe that the advice from Jeffries and consultants was that they were in a weak cash position, that they might run out mid 2014 and BP would wait to strike a deal when AMRN HAD to get a deal. They would let AMRN launch, spend a ton of money launching, use a weaker third party sales force and then swoop in mid 2014 with a partnership deal AMRN had to take. I believe the raise portends AMRN's position that they really want to partner #1 but that they needed to be in a better position to negotiate from. To me it is the only thing that make sense for the timing of the money raise.
I don't think AMRN wants to wait to the last minute to partner because they would like time to plan launch with Partner. However, it is entirely possible BP will not commit until Anchor approval. The money raise does give AMRN some leverage in continued negotiations. All speculation but I can't fathom another scenario where raising the amount of money and the timing of raising makes any sense.
I think you can get a pretty good idea on their plans. Management has never lied as far as I can tell. They gave deadlines Anchor submission, combo results and other things and always came through.
They stated 3 options for Marine launch and was accurate.
JZ has been pretty clear, they will NOT directly hire a sales force for Anchor. That was reiterated by JPM in the note yesterday.
So here is what will happen
Either
1) They will hire a third party sales force for GIA with no partner but with lower costs for a sales force
2) They will partner with BP and use BP sales force
3)They will sell out completely to BP
I'd say it's 60% on #2, 39% on #1 and 1% on #3 for odds but hopefully we learn more at 2Q CC. I hope it's a Partnership and hope odds are higher for that than I list but with little information coming out can only go on what JZ said in the past which is partner for Anchor is #1 option. Just unclear what type of partnerships they've been offered and if they will be forced to go with #2
Once Anchor is approved they have FDA backing that Vascepa is better so it will be a much easier sell
I think the markets are as big as they say but they will not realize that size of the market unless reduce it is positive. Doctors are in love with statins and have outcome study to show it helps. Realistically the same market for statins would be for AMRN if reduce it is positive. However you have some doctors that are fine with no fish oil and just statins so that percent of the market is out until Reduce it , then you have the established Lovaza which has been out for years and in combo with statins has been working in the eyes of the doctors an their patients so why switch? Then you have tha for 60 or more percent of people it is cheaper on their insurance to have Lovaza.
Lovaza has 1 billion US but is probably light in Anchor indication because is off label so a percent of doctors will just not prescribe off label so market potential should be much higher. Once Anchor is approved Vascepa should move to being cheaper than Lovaza, that is one thing a BP partner could help with, getting insurance to deny any Lovaza off label script reimbursement and forcing the switch to Vascepa, I am concerned AMRN with no partner will not have the pull with insurance companies to pull that off quickly.
So before Reduceit I think you can get 2-3 billion peak sales, if REDUCEIT is positive the large market they talk about suddenly becomes fact and 10 billion peak sales is reasonable. how fast they get to peak sales is 100 percent about Anchor launch and partner and insurance cost.
We can go from higher cost, same market and small green sales force, to lower cost, larger market and experienced BP sales force. That is the Anchor challenge and should be the goal from day 1 of Anchor launch. The right partner is worth a ton regardless of selling the asset short, management has to get an experienced sales force through a partner.
JPM dropped sales forecast to
6 mill q2
8 mil q3
13 mill q4
29 mill 2013
165 mil 2014
378 mil 2015
558 mil 2016
Unclear if they got those revenues for q2 and q3 based on info from meeting with company, lets hope not.
It is also unclear if these numbers factor in Anchor at all and If they based on Anchor GIA scenario or what.
Q2 sales report will be interesting and allow better estimates going forward.
Interesting Anchor partner near approval and not after Adcom, would think partner would want time to work details of launch.
In 1 sentence says has enough cash for standalone launch and then says not planning to hire many more reps which indicates raise was negotiating tactic for partner but if partner does not materialize they are hiring a third party force. So those look like two main options for Anchor.
It looks like they dropped 3 bucks for dilution and 3 bucks for disappointing sales.
Too bad nothing related to why sales are not taking larger Lovaza market share.
I do not see reason for me to add, still have core position but been waiting since December to add but now I feel market due for short term pullback, Aug and Sept historically weak months so market trend might be ST negative and AMRN catalyst is October so right now will review after 2 q CC but with nothing earth shattering will go with late September to add to position and expect stock will be between 4 and 6 somewhere at that time. If it ever gets to 4 I will be all in.
At this point any Anchor partnership will jump the price, even a bad one.
Maybe it is not happening very often? Don't know but if it is happening the only reason it would help stock is because it would lead to more sales.
So, in reality, we just need to see more sales as Tier 2 announcement not followed by increased sales puts the stock back where it started.
Though, I agree, if happening, there is no harm in press releasing it, helps keep us informed with the progress even if WS does not care.
What I am saying is WITHOUT the patents 2017 we could have generics so The patent protection(which they have) is huge(even though WS ignores it) and I am assuming worst case they won't face generics until after 2020 when some patents expire, I "hope" until 2030 but really have no idea how strong the patents are and which ones are strong and expire when etc...
How strong are the patents? I have no idea and have not seen much in depth analysis from patent attorneys but I assume a few must be strong and worst case 2020 before generics, best case 2030.
The call options would jump to a price near the BO and then you would sell them. If you waited until the actual closing date and that date was before the option expiry date(why would anyone do that) then they would execute and basically the same thing but just much later.
So, logically you would close out your options position after the BO and before the actual close
I agree. It's all about Anchor, lack of clarity on Anchor launch is holding back any buyers.
I think Tim Cook is a major public figure and Apple is such an influential stock a little different than AMRN and their CEO.
Will see what Joe says at next CC. I agree in the right moment the CEO can use a little "aggressiveness" in his belief in the company.
It would be nice for them to give guidance. I am thinking they still won't.
I would guide 15 million Q3 and 22.5 million Q4, with Q2 expected 10.4 that gives you 2013 guidance of 50 million(and January was not a sales month).
That is the pace they are currently on. Yes, maybe they can see some momentum from tier 2 or something else and then can guide a bit higher but the lowest possible guidance leads to beats like Apple was always famous for. Set low estimates and then beat them, hey stock jumps.
Stock would take a ST hit from the lowered estimates but then would recover each quarter once they at least met, and hopefully beat, estimates.
They can even guide 2014 Marine sales at 120 million or so and then say Anchor sales are unknown but would add to that.
But the stock price will be effected by script numbers and Anchor related news. They just do not have the script numbers to get WS excited. They are in a nice steady uptrend but not blowing the doors off for sure. Nothing in scripts says WS needs to buy now.
I just don't see any comments that support the stock having any lasting effect but since, as CEO Joe has to speak at the CC you might as well be positive.
Was not a large study but the science does seem to keep adding up that Reduce IT will be successful, even if it's just in certain aspects of the results.
6 years from first dosing is December 2017 so we are COULD be 4.5 years from those answers, likely sooner but not necessarily so.
In the meantime company needs to get Anchor launch 100% right. The patent protection is huge, you don't want to hit 2017 and then have generics hit right after and then fight with doctors and insurance to keep the generics out of Reduce IT population.
The company is doing a lot right for the long term but they now need to execute at a high level with Anchor and thus the next 6 months is crucial as to whether they will need to sell out before Reduce IT at a low ball price or whether they can have the finances to force a reasonable BO before Reduce IT.
I don't think most of us want to sit around $5 for 4.5 years hoping for Reduce IT Results.
Excerpts from new EPA study:
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-13-0257/_pdf
Taking all the findings into consideration, even when statin
treatment reduced the serum LDL-C level to <100mg/dl, there
was still an underlying residual risk of developing ACS in
patients with low serum EPA levels. It is possible that administration of EPA may reduce the residual risk of future cardiovascular events in patients who have received statin therapy
and have a mean LDL-C <100mg/dl.
We have shown in this study that low serum EPA and EPA+
DHA levels, but not the DHA level alone, were independently associated with coronary CTA findings, including the
extent of coronary plaques and their characteristics. Several
interventional studies have demonstrated that treatment with
EPA+DHA or EPA alone reduced the number of cardiac
events.7,8
Administration of DHA alone has not been reported
to do so.
Several studies have reported that the EPA/AA ratio is
associated with cardiac events36,37 because of the competition
between EPA and AA for enzymatic metabolism.25 Our present
study showed that the accuracy of the serum EPA level for
predicting NCPs was almost equal to that of the EPA/AA ratio
CONCLUSIONS
A low serum EPA level is associated with the presence and
extent of NCPs and the high-risk feature of LDPs with PR,
detected by coronary CTA, in patients with suspected or proven CAD who are undergoing statin treatment. These results
suggest that there is a residual risk of cardiovascular events in
patients receiving statin treatment. Administration of supplemental EPA may prevent plaque progression and alter plaque
characteristics.
With the last year stock price you have every reason to, let's hope by this time next year we all have the opposite feeling
If you take the 3 funds listed:
Abingworth Bioventures V Co-Invest Growth Equity Fund LP
and
Abingworth Bioventures V L.P.
and
Abingworth Bioequities Master Fund Limited
they add up to 8,195,170 which is what Abingworth LLP owns in total so pretty clear to me they are breaking down the subsidiary ownership but that the total is still just 8 million.
I would say pretty clear the filing is to update that since dilution they own less than 5% of the company. So just paperwork and nothing else. No Sales or Buys.
It does not look like they sold any shares. It still says they own 8 million shares with 3.6 in two of there funds and a balance in a another fund.
Since they now own 4.8% I believe the filing is because shares outstanding went up and they no longer own 5% or more of the company
So it seems necessary to amend the previous filing which was required due to over 5% ownership which with the dilution no longer applies.
So, correct me if I'm wrong but appears they have not sold anything this year. Interesting with loss of board member that they are still holding, I'd say that's LT bullish if they continue to hold.
How much did they sell? They no longer have board representation so that usually means they would exit their position, I can't find the filing, do you have a link
They had 8 million shares March 31, someone on ST says they have 3.6 million now so sold just over half if that is accurate, would not be surprised if sold the rest this Q and would not be surprised they held some for future gains.
Since they are off the board not putting much stock in them selling though if they did not sell all would be a boost of confidence in LT prospects.
Nobody has a clue.
My only guess is since NCE is supposed to require an Adcom and there was not one. I think originally the lawsuits over NCE created new guidelines which were not approved until May 2013 and AMRN is the first major drug caught up in NCE decision and with Anchor Adcom FDA probably said, let's wait until Adcom and discuss at Adcom.
Will be interested to see if Adcom mention NCE at all. If not then maybe they want Anchor approval to use as backup when GSK says Lovaza has same active ingredient and they can say, well if it did, it would have had same effect in Anchor population but you are not approved for that an they are.
Otherwise, no idea.
What you say is what I expect also, though maybe right after Adcom and before December approval.
I am a little concerned about the recent wording mentioning "if GIA for Anchor", really waiting on next CC to take a bigger position or not. Need to see what JZ says about Anchor. I believe partnership is #1 to them but want to get some reassurance.
Partnership on favorable terms for Anchor is paramount for stock price. They may need to take less than they want and less control than they want but they need to do it as WS wants it.
VVUS basically had a large shareholder take over the board and appoint a CEO because VVUS did not partner for their drug. JZ beware!
ARNA partnered and not doing a whole lot better to start than VVUS though slightly better. So its not a be all end all but AMRN is attacking PCP's with a large market and GSK trying to cut them down at every turn since GSK has so much off label useage.
The right partner and Vascepa could do 1 billion in year 1, no partner and we could see 200 million in year 1.
Script numbers mildly disappointing at 4507. Still looking for the "bump" with tier 2 coverage.
The miss was in new scripts as it was lower in new scripts than it was Week Ending 6/28 and 6/14 so no new upward momentum from Tier 2 coverage. When we see that # getting better each week we know Tier 2 has started to have an effect.
Second week of July is heavy with vacation also so some effect there on new scripts. If they had gotten 2800 new scripts, a bump from a few weeks ago we would be at 4750 which is about where I estimated based on trend. I hoped for 5K as I hoped to see an up-kick in the trend for new scripts.
3Q revenue estimates should come down after 2 Q CC and with these type of script #'s. At this pace we are looking for 3Q at 20 million tops. Could be as low as 15 million.
4Q gets 19-25 million range unless pace picks up so looking at 50 million this year in sales if pace does not start to increase.
Same pace gives you 119 million from Marine in 2014.
So new estimates of sales at current pace
2Q 2013: 10.4
3Q 2013: 17.5
4Q 2013: 20.0
2013 Year: 50.2
2014 Year Marine: 119 million
Anchor will have the full year also, they will have 5 times the sales force, so you have to expect some multiple of Marine, at 5 times marine sales of 2013 you get 250 million Anchor and 118 million Marine or 368 million.
44 cents a share for 2014 at 15 P/E is 6.60 per share.
If Anchor does 5 times 2014 Marine Sales or 595 million you get 1.29 per share and 15 P/E is 19.35 per share stock price so huge range totally dependent on Anchor and then if there is a partner and sales do not go even higher you need to split off some of that revenue to the partner(though also lowering expenses)
AGAIN, this is IF CURRENT pace is maintained and Anchor sales for first year are 5 times Marine sales for first year. I would expect trend would increase as more tier 2 and expect large Anchor increases due to Lovaza having 600-700 million off label that should be forced to go to Vascepa. Once we start seeing better trend and pace of scripts can adjust #'s but going along as we are now AKA worst case scenario I think is accurate above.
I don't see the citizens petition holding up NCE decision as you state.
1) The citizens petition was sent 6-7 months after Vascepa approval-Why the 6-7 month delay to begin with then?
2) The petition is NOT asking to have icosapent ethyl to be added to the OB or label for Lovaza
3) The petition is to change the weight description to only list the total weight of active ingredients
Currently Lovaza label is "1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS"
What they are arguing is that other drugs just list the active ingredient.
As they state in there argument
"Although the reference to
900MG — standing alone — would be consistent with that framework, the other properties FDA included in the description of the product strength are not."
They would not have even filed the petition IF the OB listed them as 900 MG of ethyl esters. The complaint is that they also weigh out the total pill so any filler or whatever is also listed in the OB which they are saying is not an accurate way to list it.
In a nutshell the argument is:(excerpt)
"Instead, the current strength listing gives undue prominence and inappropriate importance to the 1GM product weight/fill weight of the Lovaza Capsule — a parameter which is driven by excipients and other factors presumably delineated in the Lovaza NDA that are not relevant to product strength. As a result, the current strength adopted by FDA does not plainly (and singularly) identify the amount of active ingredient per capsule."
Since there is 840 mg on the label between 465 EPA and 375 DHA they are also OK with 840 mg on the label.
They do mention Vascepa as an example where a similar drug(and one they note has EPA-sames as the Vascepa as below
"One notable example is the Agency's recent approval of a related drug product, Vascepa (icosapent ethyl), whose active ingredient is the same as the more prominent of the two major omega-3-acid ethyl esters in Lovaza. For Vascepa, as reflected in the Orange Book, FDA adopted a strength of 1GM, which is the amount of active
ingredient in an administration unit as identified in the drug labeling."
However the sole purpose of the mention is to show how the labeling for Vascepa is active ingredient ONLY and for Lovaza it has active ingredient and total weight.
THEY ARE ONLY ASKING FOR A CHANGE TO THE LABEL TO LIST JUST THE ACTIVE INGREDIENT WEIGHT.
THIS HAS NOTHING TO DO WITH NCE AND VASCEPA.
Once this is decided it has zero bearing on NCE. My guess is your CDER was throwing anything out there so you'd stop bothering them and I'm sure YOU mentioned this petition and they just didn't deny it because there is nothing in that petition which would have any effect on NCE.
They responded via FAQ on the website.
The study did not use Vassepa and has nothing to do with Vascepa so it would be hard for them to get giant media coverage like the initial report.
They cannot come out and say anything definitive on a study they had no involvement in so not sure what people think they would say that would get any type of play that would be factual and be picke dup by mass media.
In 2011 when the same people said DHA causes cancer, the same thing happenned and GSK, as they are also doing now, ignored them and let the science community debunk.
GSK is more in the target hairs of this false report and they are doing the same as AMRN, actually less as AMRN, at least AMRN addressed on their website. GSK is doing what you are supposed to do, ignoring it, if you spend time attacking it all you do is give it some legitimacy.
YES Reduce IT is past 50% enrollment and has been since at least February but more likely by end of 2012 so it highly likely Anchor data has been allowed since the beginning of the launch.
We know it is 50% enrolled because that was the requirement of the FDA for substantially underway which at the end of February they submitted for Anchor approval.
We also know because the company in press releases previously said they expected 50% enrollment by end of 2012. I'm also pretty sure in one of the CC's or presentations the company mentioned they could use the Anchor data in sales.
So the Anchor data is old news, has been available for use from day 1 of launch.
THE NEW QUESTION is can sales people discuss the JELIS results with doctors and, if so, has that always been the case, or has that only been allowed starting in August.
Since JELIS has nothing to do with Anchor and Marine per se as it is a REDUCE IT type trial it makes no sense that it would have restrictions and then have them lifted in August.
It seems it would always have been allowed or would not be allowed until REDUCE IT results.
Then again, it is a non-FDA study that was NOT using Vascepa but a similar product so perhaps FDA took some time to analyze before allowing.
It will be helpful to go to PCP's for Anchor and say, Vascepa showed in JELIS study that in this population of people it reduces cardiac events, we are doing a larger study on US population to verify but with no side effects and JELIS showing it can prevent some cardiac events, why not put your patients on it? BTW DHA/EPA fish oil does not have any studies showing the same benefit.
That would be a great selling point and not something most PCP's would be aware of already. So is important to know if they are allowed to do that or not.
I imagine someone if just called IR and talks to Joe and he can answer whether they were Prohibited from discussing the JELIS results and if that has changed, I am not sure why they would have been prohibited from talking about it before August but FDA has guidelines for what you can do in selling so should knows. They have had it in every presentation so seems weird that the sales people cannot bring it up In sales calls before now
I'm not sure it's big news in regards to near term sales, I think the biggest thing it does is give more credence to Anchor on time approval.
However, Anchor is a slam dunk as it gets so not really sure that's much of a question. The fact they can use the JELIS study results at all with FDA approval is interesting though.
Since most of Anchor Will be geared toward PCP's and they have been through cardiologists several times perhaps this will help them as they start expanding to PCP's on a wider level. It is also good to have several months to see how the JELIS study plays with doctors, will give them some help on how to sell the Anchor indication as they get some time to learn what works well and what doesn't.
I think the Pfizer news is more interesting but since that was not presented as strongly it is kind of glossed over as pure rumor. They need a BP partner, Pfizer they have relationships with and makes the most sense in that way, good to hear they may have interest in being the partner. A BP partner with a fair deal and the stock is over 10 right away and header for over 15 and would mean large Anchor sales in year 1 of Anchor.
Copy of Jeerios statement below
rec'd call from fund source with ++ co sales contact, FDA has approved company use of A + JELIS results for sales calls beginning in August
this is potentially huge in relation to sales and the run to Anchor allows company to warm up the space well in advance.
Also, word was that PFE definitely in the mix for a deal. but the FDA part was presented as hard fact.
as was relayed to me, co can use A + JELIS data soon. whether that turns to off-label is docs choice i suppose.
seems like a left-field out of blue thing, but trust me, this guy never calls me. i call him. so this was notable. doubt any PR ppl.
this is a subtlety of co relationship w FDA, not PR fodder. but, WS types will be able to verify w their CV doc contacts.
I always thought NCE post marine approval could have got a deal done. BP would know they had exclusivity thru 2020 at least. The stock was around 15 so a 25-30 dollar buyout could be sold to BP shareholders. Once AMRN had to launch marine it was over as BP needs to wait for Anchor sales in order to justify a BO. There is no way a BP will justify to shareholders a 4-5 times multiple on buying AMRN with 12 million in sales to date, it would make more sense to try to partner and then once you help get sales up you can purchase the company with a more reasonable markup with price back over 15.
I do not see a scenario of a BO until mid to late 2014 as Anchor sales and launch need to be 6+ months in. I do believe any partner on selling Vascepa would have inside track to purchase AMRN but would not expect BO talks to pick back up for a year at least
Accept #3 involves more trials and more costs which can only be done by BP. it has value but long term value and not without cost so doubt it adds a ton of value to AMRN currently.
In 10 years when we all can get Vascepa OTC it'll be good to have this knowledge.
When you read reviews of Plusepa most of them are geared towards people with depression and most of them are positive reviewed against depression. Even though there are generic Prilosec the Name brand stills ells OTC. So there is added value because it is highly likely Vascepa will one day be OTC and then all these other uses will be helpful. That day is very far away however, all AMRN management can promote to s reducing Very High trigs and soon High trigs. None of these other things are proven in an FDA study.
Transcription off a little but also it was coordinated with the powerpoint presentation so need to follow along with that to get he was highlighting things up their visually. These conferences are educational/advertising and much more detail can happen in the break outs.
AMRN is also being very conservative with what they say, following the guidelines strictly to avoid any issues with FDA with Anchor still pending.
These presentations are not known as Apple announcements with great fanfare, small groups, analysts and doctors mainly is the focus.
I'm not sure the companies feel they get much out of these presentations anyways but helps to make friends with Jeffries and Citi etc...who will then scratch your back on an offering and buy your shares.
When you are invested in the company you put too much emphasis on these presentations. They generally don't accomplish much.