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Hi Kiwi,
The "answer":
- They have to evaluate the possibility of earlier interim analysis
- If it is not possible their next steps (partner or dilute) will be due around mid-2015 and it will be based on / influenced by the actual P&L (scripts) number
I know only one thing: stop the R-IT is not an option, as we have to forget ANCHOR approval (the best case is the ANCHOR data will be included on the label, however do not forget that Lovaza's study data of 200-500 mg /dl was removed from label earlier this year).
R-IT SPA predefined one interim analysis at 60%, however it is not forbidden to make additional analysis without SPA modification, since analysis not equal with unblinding the study, The sponsor does not known the result, just the DMC and the statisticians.
For 90% power R-IT has to show at least x% eff. at y %(number) of events:
15% / 100% (1,612) / acc. to SPA
19% / 60% (967) / acc. to SPA
20% / 55% (887)
20.75% / 50% (806)
22% / 45% (725)
23% / 40% (645)
24.25% / 35% (564)
26% / 30% (484)
As of today R-IT could meet with the 26% / 30% (484) only.
Let me describe some topic (it just a summary of facts):
FDA “proposals” of SPA, placebo, early stop the study, etc.:
- FDA never propose anything, they accept (or not) the sponsor’s proposals.
- If they accept something it does not mean that they could not challenge it later. They conclusion / opinion is always follow-up and not prior.
SPA appeal / SPA legal case:
- AMRN could not go to the court without go through the entire appeal process
- according to my best knowledge 2 levels left (JW and MH, JW is a member of MPC)
- the appeal is as like court case where the judge and the prosecutor is the same (FDA)
- sponsor could requests a meeting as part of its appeal and the FDA should either grant or deny the meeting request
- all other action could be initiated by FDA only: additional clarifying information from the sponsor, meeting with the sponsor, limited discussion with one or more members of an advisory committee or internal or external experts, advisory committee review
SPA / sNDA:
- SPA is the agreement on the design and size of clinical trials and on the criteria of sNDA submission. SPA intended to form the primary basis of an efficacy claim in a marketing application (sNDA).
- if the sponsor completed the trial according to the SPA and the result support the approval of sNDA, the approval is likely, however not guaranteed, since the SPA is the primary basis and not the one and only.
- sNDA could be submitted, approved without SPA. However, everybody has to decide, Is it a realistic expectation or not, after the DMEP, that will make decision about the sNDA, rescinded the SPA.
R-IT:
- any study could be stopped early due to safety or efficiency reason.
- to stop due to safety issue is easier, possible without any analysis, just based on events.
- to stop due to efficiency is possible after analysis and meet with stopping rules. In this case the DMC propose the stop, the SC agree or not, if yes the sponsor has the final word: stop or continue (FDA was not involved in this process.)
- according to my best knowledge early stop due to efficiency was based on the first or later predefined interim analysis at every study, no trial was stopped before the first interim analysis
zumantu,
"Amarin can get trending info on R-It" and "maintain the blinding integrity" could not happen together, they are opposite. I am not 100% sure: The data will be still blinded for Amarin at the time of DMC's recommendation (stop the study) and they will get it if they agree and stop the study, otherwise (continue the study) it could be biased.
Amarin could do the following steps regarding ANCHOR:
a.) try to agree with FDA about second, earlier interim analysis ie.: at 50% / 805 events, we need at least 20,75% eff. for 90% power. (with 25% eff. it will be around July 2015)
b.) it's not mine (cited by louieblouie #34191), but a good idea: submit the ANCHOR sNDA as accelerated approval under subpart (h), or if possible (?) change the type of the current submission
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birzinho,
I did not take anything personally, my posts qualify me. Yes, sometimes I am wrong, but I have a logic always. The current situation at least is not good (I am a long also), however we could not ignore the facts to confirm our expectations. JJ will not wake-up on Monday as "Oh, Jesus, I would like to wrote "reinstatement" and not "uphold".
MLK weekend was about the negotiation (if any) and not about "I have a dream ..."
Do not expect anything from NCE case regarding ANCHOR SPA, since the two items are not related legally. The NCE ruling (my view: will be in favor of AMRN) will not change anything regarding the SPA issue. ANCHOR could be approved as b.) above only under the current circumstances.
To be more precise: DMEP could approve the sNDA without SPA, however they rescinded it as they have to approve it with SPA (after the successful study), so I do not think they will. The best: data will be included on the label.
Basically I do not say they do not have to sue FDA regarding the SPA (Maybe they will due to shareholders expectation). I said they could not win it (the main argument not the process as they rescinded it, but the basis "new scientific evidence is required") and / or at the time of the ruling it will be more or less irrelevant.
Suing for damages? I do not know/think it is worth any penny. As I wrote they can win regarding the process as FDA rescinded the SPA only and claim unrealized profit between Dec 20, 2013 and approval of R-IT due to the rescission and it is at least not easy to determine the value of it.
For the avoidance of doubt, the decrease of pps is not equal with the loss of the company till they do not dilute. The company financial situation exactly the same as it was on Thursday. The company outlook was changed ...
ziploc_1: "moot" or "mute"? I guess "mute" ...
Sometimes the simplest answer is the right answer. They (FDA) are bureaucrat (droid) entirely, not just on low- or mid-level. Sad to see "Curve Tech Investing" has right.
btw: I do not see the difference between your and mine opinions ...
JL,
You are entitled to your opinions also.
My opinion always based on my best knowledge at the time of the opinion. I could not paint a bright, short-term future, since no real basis for that. It could better ($2-4 pps) IF the script number climbing and V will be in more Tier 2, but it will not $7+ on a short/middle-term without ANCHOR / before R-IT result.
Yes, I expected the reinstatement as OND was the real (and one and only) level where the possibility of reinstatement was significant due to the level, new studies, etc.. However, as you know also, OND uphold the rescission yesterday… I was wrong. Or do you still think OND will reinstate the SPA? …
You could call my opinion as “mantle of gloom” but it looks like as a reality. Or do you think that JW or MH will overturn the decision? Or if not do you think that the court will decide before mid-2017? If yes, when? What is your opinion - short-, mid- long-term – regarding of ANCHOR indication? We could live in a dream …
Furthermore, it is irrelevant that FDA has right or not, legal or not, since they did it and I do not see a real possibility that they will change it.
I agree with you that R-IT data could be good enough by mid-2015, however it will not be analyzed under the current SPA terms. AMRN has to agree with FDA to change the SPA and set-up a “second”, earlier (lower) interim event number. Or do you know any study that was stopped before the first interim analysis?
Yes, all of these are not inspiring, but I could not be short of facts and reality.
And yes, you have right, I will stop to write any opinion about the future of AMRN if I close my position anytime. I am evaluating the situation and potential next steps now.
JL,
FDA did not offered anything. FDA agreed with AMRN on the design and size of clinical trials and the criteria of sNDA submission. SPA intended to form the primary basis of an efficacy claim in a marketing application.
The successful ANCHOR study and R-IT substantially underway were the criteria of sNDA submission and not of the indication (drug franchise). The SPA could be invalidated (not binding) due to four reasons. Three of them could not be used in case of ANCHOR. The only terms that would allow the FDA to vacate this agreement were new scientific issues arising after the agreement involving safety or efficacy. They did, so they could not breach an invalidated, vacated "contract".
I agree with you that they reason is weak, at least questionable, however legally they could rescinded the SPA based on it and I am sure FDA could also invite huge bodies of experts who will testify why R-IT result is necessary, and ANCHOR study is not enough for approval.
“The first question the judge will ask the FDA is..I*f there is proof V does not work, then why is the REDUCE-IT study still going on.” The answer is simple: “We do not have a proof V does not work, but we do not have a proof V does work, so we would like to see R-IT result to determine the efficacy of V regarding CVE, since the only reason I could think of to lower triglycerides or raise HDL or change LDL composition, Apo B levels, particle size -- the only reason to want to do that is to prevent cardiovascular events. I can't think of any other reason to do that”. (Dr. Hiatt / AdCom)
But make the long story short, as I wrote the ruling of the case is indifferent as it will be around mid-2017, after the interim analysis (if R-IT already stopped due to eff. AMRN will drop the case) or 6 months before the final result.
They will send a CRL at the end of the appeal process and the best that we could expect they will allow to include ANCHOR result as “Other study” on the label, but definitely not as an indication. (The possibility is low as they removed the 200-500 data of Lovaza early this year.)
It is about ANCHOR, not R-IT.
JSchaible's two cents (cited by louieblouie #34191 ).
Jupiter was stopped after the second interim analysis. Hopefully R-IT will be stopped around Q2-Q3 2016 after the interim analysis.
As I know at the time of the 967 events analysis will be done and if the DMC think (minimum that data meet with stopping rules boundaries) they will recommend the stop.
Sterrin Commitee also judge the result.
The sponsor has a option to accept or decline the proposal.
I think that the sponsor does not have access to (all) date at this time, otherwise in case of continue the study could be biased.
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I do not think that patents could force AZN, they did not pay too much for Epanova.
"potential for events by late 2015" - Not exactly, my view mid-2016 as earliest
Z-
Good find, however it makes stronger my view: no early stop before the first interim analysis. (I hope you like my previous post and did not take personally )
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Hard to say anything …
OND was the real (and one and only) level where the possibility of reinstatement was significant (or at least higher than at other levels). I do not think that JW or MH will overturn it (especially as JW is a member of MPC) without external influence or new, very, very … strong study result (p > 0,99999 ). AMRN (maybe) will appeal one more round to JW. If it’s two round (MH) they will go to the court after that, however no way that any judge will rule against FDA in a scientific issue (max. a positive ruling regarding the “timing” and method).
But let’s assume judge will rule favor of AMRN … now, mid-September – JW’s decision around mid-Dec – MH’s mid-March 15 – submit the Complaint: mid-April 15 – judge’s ruling: mid-2017 … at this time it will be indifferent.
967th event will be around Nov 2015 – Jan 2016 (with 15%-25% eff. – or Jan 2016 – Jun 2016 with 27% - 49%.) The power should be 90% as a minimum and it is true over 19% eff. (967 @ Dec 2015 with 2,74 years avg. follow-up). The analysis will take – I guess – 2-3 months, AMRN could get recommendation, to stop the study, from DMC around Feb (19% eff.) – July 2016 (40% eff.). , so the study will be stopped (or not) 1 year before the court ruling… (But not earlier). If the study will not stopped based on interim analysis we will see the final result around end of 2017 (1612 events July 2017, result Q4 2017) within 6 months after the ruling.
I do not think R-IT’s SPA will be rescinded. Primary Endpoint is hard outcome, CVE, not surrogate end-point. Furthermore, I do not think that FDA will play the mineral oil “card” – btw: their conclusion was fair in the BD, however they did not have to raise the topic at all… - as it could be used based on lipid parameters only and the placebo CVE number could be compared with statin’s trials and I do not expect a diff. between R-IT placebo and statin trial active arm.
If R-IT is positive (likely) it will be approved.
Meanwhile, the current task is: scripts and insurance coverage (Tier 2), they have to continue R-IT, as it is the future of the company. On a long term they could not survive with MARINE and off-label ANCHOR only. Between now and mid-2016 the pps will depends on the actual script number, unless something unexpected will be happen.
NCE case: I think AMRN will win, but it will has not material effect on the company situation at that time, “just“ give additional two years till 2017. btw: maybe it will be enough if R-IT is positive (likely)
JSchaible two cents (cited by louieblouie #34191 is an excellent idea, good point, worth to try simultaneously with the necessary steps but definitely not instead of them. btw: it is a good example how to answer the question without the answer:
DR. HARRELL: I'd just appreciate a very brief statement from the division about their current thinking about conditional approval.
DR. PARKS: Can you explain what you mean by conditional approval?
DR. HARRELL: Approval subject to an ongoing clinical trial showing something.
DR. PARKS: I think what you're referring to are the situations in which the agency can require a clinical trial to be conducted as a condition of the approval. There are four scenarios in which the agency can require such trials -- accelerated approval under subpart (h), which this application is not subject to; that was never a matter of discussion -- that's my understanding; is that correct -- during development. The other areas are deferred pediatric study, so that's obviously not going to relate to this one; the Animal Rule; and the fourth one would be under FDAAA, which is for safety reasons. So if there is a safety concern related to the product or new safety information if the product's already been approved on the market, then the agency can require a study with specific timelines that are to be met by the company to answer the question of both efficacy and safety -- well, safety for the FDAAA. For efficacy, that would be under accelerated approval. But again, that was not something that was discussed with this application.
I know him. I have a lot of friends (letters) and they are together a group (words). Sometimes we are reading ... try it
"This DMC recommendation is based on a predefined interim analysis ..."
WRONG. Next idea?
JL-
Not challenging you but I could not find any study which was stopped before the first interim analysis. Did you?
L-
I agree „delay” does not mean anything (either bad or good). I worried a little bit till yesterday as they already received a “no” and not communicate just on the quarterly call as the last two times (no and delay), but JZ made it clear that they will communicate the no also.
My view is different about MPC involvement, it is a positive sign since JJ easily could say “no” alone, he does not need a support for this. I think he has – at least – some doubt regarding the two lower levels actions. I think he involved MPC:
a.) could not decide alone …
b.) it will be a reinstatement, but with this step they could “defend” their previous action (DMEP & ODE II) – it was complex, new info, etc. and he will have some explanation to DMEP & ODE II also …
We will see… however if it will be no, the SPA lawsuit is still away (at least 6 months) since they have to go through JW & MH.
Agree, all these events will have no affect.
I do not have any idea regarding the duration of 1st amendment judgment. Furthermore, I have additional question: which is first? Judgment or using ANCHOR data usage? Will they request a preapproval or will pretend their action?
It’s amazing that some folks expected a Q&A session yesterday. They thought it is a Conference Call …
Before I forget, I think we could agree that ... Öööö ... John ö Thero is not the Öööö... best öööö.. presenter in the ... Öööö world....
Meanwhile I agree you - overturn is more reasonable - I do not think time is a factor.
I mean that every governmental office / employees react as latest as possible (in this case 30 days after the MPC advice). It not depends on the importance or the complexity of the issue. They are droid (respect to few) without real responsibility. Do you think that DMEP - after rescind the SPA - did anything with the appeal? I think no ... wait and issued the uphold
I never heard a story about a governmental employee who was fired because regularly missed the deadlines ...
The "good" thing, JT saidy esterday that all type of decision (yes/no/delay - working group of MPC) will be communicated "immediately".
If the 08/14 market reaction was related to MPC advice, we will see the 8-K / PR this week or Monday morning as the latest.
btw: we are "lucky" since FDA kept all deadline YTD
L-
I think Ajax shared the info that he got. No more no less regarding him.
I have questions regarding the info itself (not demand a proof, just try to find the logic)
The info was:
- SPA back on the table, modify the SPA: Let me assume it is ANCHOR SPA, but correct me if I am wrong. I know I repeat myself: but how any SPA could be modified to mean anything if the related study was finished, data was analyzed, report was issued. SPA is not about indication or label, so AMRN could accept any modification, since it not affect anything.
- Vascepa could be marketed for 200-500 TG mg / dl: FDA argument is that it is not necessary, but OK they changed their mind. Do you think AMRN refuse it?
- FDA would like to include BBW as "The effect of VASCEPA on cardiovascular mortality and morbidity has not been determined". The only difference to "not compromised label" is the BBW, the text itself was and will be the part of ANCHOR label. Do you think AMRN refuse it?
It is not questionable that the rumor was on the market in January, but I still do not see any logic that confirms it.
You have right "equal" discussions take place between two parties to "settle" between the FDA and sponsors during the official appeals process. It is part of the process, could be requested by FDA or by the sponsor.
However I still believe that - as I wrote - that no "equal" NEGOTIATIONS EVER take place between two parties to "settle" between the FDA and sponsors. It is true for all governmental offices anywhere in the world.
The good news that we do not have to speculate why no 8-K / PR? (ie.: they received a "no" but will communicate during the next Earnings CC as last time)
They will communicate "immediately" the OND's decision: yes / no / delay
Conference:
As expected, business as usual conference
No new info from FDA to disclose
They will release 8-K in both (yes or no by JJ) case
Hi Biwatch,
Thx, however I am still confused a little bit. I started to apply the 5.2% overall rate, since:
FDA BD: "It is expected that a minimum of 1612 primary efficacy endpoint events and approximately 6990 patients are needed to detect a 15% relative risk reduction in the primary CV endpoint with 90% power and a placebo event rate of 5.9% per year during a median follow-up of 4 years."
Amarin BD: nothing about event rate
FDA slide show: "Expected placebo annual event rate 5.2%"
Amarin slide show: Reduce-It Primary MACE Event Projections CO-73
They are using one line only as 5,2% (One line suggest: it is for active and placebo arms together)
and they could say "lower than expected event rate" if compare the available overall with the planned overall.
FDA BD wording is the same as yours except the rate. btw: Where you find the cited description?
Hi BiWatch,
Good to "see" you. What do you think about my event rate assumption?
They modified the SPA in May 2013 due to lower than expected event rate. Since they know the overall, actual event rate they have to compare it to the overall, planned event rate (5,2%). Overall, planned event rate 5,2% means 5,62% for placebo and 4,785 (with eff. 15%) for active arm.
Where we are (#event) today acc. to your calculation?
(I changed my model as split the enrollment in the period 50-50% to beginning and to the end of the period - assume that the enrollment is continuous.)
Hi All,
Pharmacydude (& Kiwi): Yes, technically possible, they have to change the SPA (negotiate with FDA). See #28220.
Additional info to that:
24.25% / 35% (564) / nearly done, we are at 541 events
26% / 30% (484) / - done, we are at 535 events
BB: We could not expect higher event rate and the follow-up time is more or less exact (I send you my R-IT model by email for details). We could be at 60% (967) if the event rate is at least 9,55% and or eff% is max. 15% …
Albino2 (& sts66): DMC can halt a trial early, based on interim analysis only if it's blatantly clear not treating the control group is ethically wrong. It is far away (2016 Q2 & Q3). They are not analyzing the study on a quarterly basis, they just follow-up the key parameters (ie.: enrollment, events, adverse events).
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Rodman & Renshaw presentation today is not special, just business as usual (it was fixed at least 1 month ago). I do not expect any announcement, it will the “same” as GS Conference in June, “however” the scenario are:
- they did not received a “no” / anything from OND (otherwise they cancel the presentation as in January): poss.: >99%
- if they received anything (yes or no) they will use the conf. (meanwhile halt the stock) to share it. pos,: <1% and I think in case of reinstatement only
Power is not effects the timing of the interim analysis. Read this.
At 967 events eff% will determine the power.
I could not find any trial that was stopped (due to eff.) before the first interim analysis.
Yes, better drug = longer period to reach the interim analysis (60% / 967 event).
Early stop could be happen based on the interim analysis only.
With the planned 15% eff. and 5,2% event rate (5,65% placebo, 4,78% Vascepa arm) we are at app. 568 event today (average follow-up 18 months).
If eff. is higher than 15% - I think yes - the event# is lower (25% = 537 event).
Regarding higher event rate, do not forget that the reason behind the SPA modification (increasing the min TG from 150 to 200) was the lower than expected event rate in May 2013. The change definitely increased the event rate, hopefully to the planned rate.
AMRN has access to data, but not to all and not by arm / patients (just to overall data) so they could not conclude anything regarding the result.
We could expect any announcement after the interim analysis (around Q2-Q3 2016 as the earliest) IF DMC (based on interim analysis and the stopping rule) will propose the stop AND IF AMRN will accept the recommendation.
I could not determine the exact time when AMRN will see any unblinded data, analysis, but definitely not before DMC recommendation (if any.)
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investor site presentation: ??? It is 1 month old
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ps. AH - 461,500 @ $2
BB, You have right but hopefully I am understandable.
The threshold is not odd in math or statistic. ie.: Defining Thresholds
Kiwi: We need BiWatch to answer your question, but I think it is not possible to calculate time and number of patients for confidence (p value)
without knowing the eff.%
We need BiWatch help to calculate it.
"85% enrollment threshold with over 6800 patients enrolled"
It is about the enrollment only.
Just for Kiwi, it is math
8000 x 85% = 6800
8000 is the total, planned enrollment
We will never know, but the last 16 trading days at least suggest that the demand is exist and not temporary.
I do not think we will see the $2,75 as in January (in a short term) OND's decision will be released earlier. It could happen if SPA will not be reinstated and scripts will climbing.
I like like this "warm-up", with decent volume before "high jump" and according to International Association of Athletics Federations's rule everybody has tree attempts ...
L-
The difference between you and me, that your sentiment based on that where we are, what is the pps today, meanwhile mine based on facts or “What would I did in the same situation?”
We know the facts in case of the procedural error early on in the appeals process only. (I also do not like the 2012 – 2014 Notes conversion, however the timing only. We could not judge that it was necessary or not, since we do not know all circumstances.) We are just speculating regarding other “mistakes”.
Theoretically, (since I still believe in reinstatement, but not sure), if the SPA will be reinstated and somebody will made $30+ offer till the end of the year, will you still think that the refusal of $20 offer, if any and GIA decision in 2012 was a mistake? I guess not, since it will be a 50% return within 2 years.
In my view none of your arguments will be valid in this case, meanwhile my opinion about procedural error will be still valid.
FDA will not pull a mea culpa, they do not have to save face since they do not have. Government and authorities never pull a mea culpa. They have always right, however their right regarding the same topic / issue are different time to time…
FDA does not have a relationship with any company, FDA’s employees have a relationship with companies’ representative. It could be good (easier to reach something, but not over the laws) or bad (harder, but FDA’s employee could not acts against the law/facts ever).
AMRN could not negotiate with the FDA, since appeal processes are not negotiations, the parties are not equal. AMRN could accepts the latest decision of FDA or continue the appeal process. DMEP issued the ruling and AMRN is challenging it. ODE II has the same opinion, however hopefully OND has a different view. This is the heart of appeal, otherwise none of the appeal could be successful.
Why DMEP rescinded the SPA? I do not know, maybe due to bad relation with JZ (they reason – referred studies -, at least, is not strong however they could use it), maybe “follow the money” (I do not believe this, since you could bribe officials, but not all of them and too many people were involved in.)
Regarding the two issues, my view is:
NCE:
The duration of the process is not acceptable, however regarding the determination (it is NME and not NCE) FDA followed their regulation, since they had been used the moiety approach to determine NCE from the beginning.
They did not breach any policy or law (as I know) when determined EPA vs entire mixture as moiety of Lovaza / Vascepa. Are they used this approach in the past? No, but it does not mean they could not, however it is irrelevant since the main question is not this.
The issue is that FDA’s regulation (as in case of Orphan Drug Exclusivity) is wrong. They could not overwrite the statue (ingredient) with their own regulation (moiety).
I am sure (based on other cases) that the Judge will rule in AMRN’s favor and NCE will be granted.
SPA:
The result of R-IT is not important for FDA in this case, since it is a different indication. They could say anytime (both case: If they will not reverse it and R-IT successful or reinstate it and R-IT will not be successful, that at the time of their ANCHOR’s decision the existing science support the decision.). R-IT will change (or not) the science itself.
The question is that what is the science today. Take into account everything (type of referred studies, subgroups of referred studies, other studies, etc.) it looks like DMEP and ODE II was wrong and hopefully OND will correct it and SPA will be reinstated.
A little bit OT, but I think all appeal process at any authority, when the first level is the same level that made the original decision are wrong, since I guess none of the decision were overturned ever, anywhere in history at this level (top of technical, procedural error).
Just take us, meanwhile we are equal, it looks like we will never agree regarding the competence of the management
Good to read. For some reason I have déjà vu ...
"FDA placed additional hurdles between ... and ... exclusivity by attempting to impose requirements that are found nowhere in the statute and that exist in regulation only"
JL,
I agree the (lomg-term) future is REDUCE-IT and the near (1-2 weeks) future is what the FDA decides to do about the SPA situation, however the middle-term (between the two) market sentiment (pps) will be based on AMRN's performance (Operating Income or Loss). Of course it will reflect the possible (and discounted) value of R-IT, but at least till interim analysis uncertainty will exist regarding the result / real value.
Regarding early stop (due to efficiency):
Maybe I am wrong, but I revised my assumption (early stop at any time) and unfortunately I have to say that early stop could come after interim analysis only. I did not find any trial that was stopped before interim analysis (ie.: Jupiter trial, which was stopped early, after the second interim analysis with 328 events and a median follow-up of 1.9 years at the recommendation of its Independent Data and Safety Monitoring Board.). If I am right, we will see the result around end of 2016. (The 967 events will be reached earlier, but analysis takes time.)
correction to #33815: " $493 interest of BioPharma, (non-cash)"
Please don't take it personally, but Wow ...!
As my basic background is finance, I was shocked … Sorry, but unfortunately, I do have to ask - did you ever see, read any of the 10-Qs or 10-Ks?
“Operating expense of $32,800,000 INCLUDES cost of goods sold”: COGS ($5,025) is “between” Net Revenue and Gross Margin (at every company not in case of AMRN only). OPEX contains Research Development ($11,727) and Selling General and Administrative ($21,094) and part ($2,289) of these are non-cash items, as "Non-cash stock-based compensation" and "Non-cash warrant related compensation (income) expense".
Interest expenses, net: $4,292 as “… consists of interest incurred under lease obligations, interest incurred under our 3.5% exchangeable notes and interest incurred under our December 2012 financing arrangement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma. Interest expense under our exchangeable notes includes the amortization of the conversion option related to our exchangeable debt, the amortization of the related debt discount and debt obligation coupon interest.”
- $1,313 interest of 2012 & 2014 Notes (3,5%)
- $647 is non-cash item as amortization of the debt discount
- $1,260 interest of BioPharma (cash, current)
- $625 interest of BioPharma (cash, deferred)
- $493 interest of BioPharma cash, (non-cash)
- $(42) interest income
KOWA fee
per 3/31/14 press release: “Amarin will compensate Kowa Pharmaceuticals America with a co-promotion fee based on a percentage of Vascepa gross margins that increase during the agreement's term, from the high single digits in 2014 to the low twenty percent levels in 2018, subject to certain adjustments.”
Q2 2014 Results - Earnings Call Transcript John Thero “Our royalty under that agreement is in the single digit here in the third (sic!) year. Some of the analyst have estimated it to be 7% to 9% range of revenues. They came on in the middle of the second quarter, so it’s not a whole lot that we have paid to them at this juncture and it’s percentage – is after gross margin as oppose to revenues so it’s a lower percentage if you calculated of a revenues. So that really is why we are very pleases with the enthusiasm and getting out and making calls on their accounts. They are just getting started, so the cost and impact from them in the second quarter as expected was fairly limited.”
All of these are not my opinion, assumptions: these are facts!
The patriotic FDA won the first half, however we are intelligent animals and we will win the game
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