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BB,
This is your best post. (Really. You could if you want.)
I agree. If I have to definitely choose between yes or no regarding reinstatement: it’s a yes (otherwise 60% yes, 40% no).
Only one comment: I do not think that this step is directly connected with NCE case.
Agree w 1bill. It's just a waste of ALL posters' time.
The "rules" very simple:
- dont qualify the other poster. If you have different view write a post (sometimes the best solution if it's a new post and not a reply)
- if you know something, post the info and not that you know something
- if you post the info provide a link or the details, not just the "headline"
- if you post your info / conclusion - if it possible - check twice before post (otherwise accept if somebody correct you with link, fact, detail)
- the topic is "Amarin" ...
- it's not Google or help desk / FAQ - do not use the board to get basic info ...
This board is useful but could me more.
It takes some times to analyze the 10-Q in details, but my quick, main conclusion. (Q2 vs Q1)
Revenue: Looks good, 12,606 vs 10,967 (vs 9,264 if we eliminate the 1,703 deferred revenue in Q1). The increase is 1,639 (3,342) however the AR increased more than 50% (6,364 vs 4,025 diff: 2,339). It suggests that they deliver a significant amount at the end of the quarter.
Gross margin: decreased from 61% to 60%. It's the first time ...
R&D: We could not expect significant decrease.
SGE: Same as R&D and could be higher since KOWA fee is booked here.
Cash-Flow: Impressive, but takes care, it's not from "operation", since operating loss was (25,240) vs (25,571)
-----
FDA: It's rather good than neutral. It suggests that Dr.Jenkins (at least) has a concern regarding the rescission by DMEP. I think that the reason to involve the Medical Policy Council is not for to delay the process. Maybe he just would like to cover every angle (or himself). It's suggest me that he is for reinstatement, but would like to get a confirmation from the Council.
It should be the last stage ... interesteng you do not have a watch
Call: 04:30:00 PM
Market Close: 04:00:00 PM
10-Q: between 04:00:01 PM - 04:29:59 PM
and the curren time: 02:47:27 PM
Guys,
It's useless. Both of you have partially rights:
mrmainstreet: It's totally acceptable and usual - not just on WS, but in any business - that somebody keep the source hidden and btw it's immaterial. AMRN never will discuss publicly the exact details of the meetings w FDA.
Ajax133: You have to accept that people require some details. In this case, not the source, but the details of the FDA's offer. ie.: I still do not know what I missed regarding the SPA, how could they change it to support approval for 200-500.
I think everybody who post a fact (not an opinion) has to provide link OR details (not the source)
Hi Ajax133,
I read all your post and see your thinking. Agree with you that FDA will do whatever they have to do to cover their butt. Unfortunately it’s true for every bureau, they try to defend all of their decision, action as long as possible and usually their biggest effort to protect their craziest, strangest decision. I think currently the main motive of FDA to not reinstate the SPA is that they rescinded it …
However, if they “want” they could do an action that still cover their butt meanwhile approve ANCHOR.
But my question is still exist: what I missed regarding the SPA? How it could affect the ANCHOR approval?
Ajax133,
Maybe I missed something, so please tell me what (do not take it as an attack I just would like to know what I missed).
SPA is to support the approval of NDA / sNDA and be the “exclusive” basis to determining the safety or effectiveness of the drug. SPA is about design, size, endpoints and other parameters (but not about indication / label)
In case of ANCHOR the DMEP said that the available data from SPA backed study is not enough to determining the effectiveness of the drug. So they rescinded the SPA, otherwise they HAVE TO approve Vascepa for ANCHOR, since endpoints met.
The study was finished, all data were available. How could they change the SPA to be enough for approval? Request less data? Request more data? I could not imagine any reason for less data. If they would like to get more data, how AMRN could provide that based on a finished study? It's equal with a new study.
Again, what I missed?
Ladavis23,
I will collect it exactly later, now let me base on my memory (interpretation): The Company never said they will stop R-IT. JT words were very carefully and well constructed, ie.: “it's current form without Anchor”.
They have only one “mission statement”, target from the beginning: get R-IT (confirmed CV reduction in 200-500) approval. All other - MARINE & ANCHOR - are just a tool. I think they never planned with ANCHOR market (200-500 without CV) longer than 5 years. MARINE is the cream on the cake (R-IT) only.
They will switch off the lamps earlier than stop R-IT.
AMRN will never cancel the R-IT trial, only if they will be “forced”. We will see news about cancelation as part of the bankruptcy announcement. (I do not think it will happen.)
Type A meeting and was denied by OND since they have to follow the protocol and could not skip DMEP and ODE II
"I believe an answer, whether it be yay or nay re: the SPA" - They "announced" ODE II's decision within 10-Q and also said "our plan is to provide updates on at least a quarterly basis, but unless there's a significant change in status we probably just update on the quarterly call"
Re: 31805 – “sNDA”: Nothing special. It’s a regularly upcoming rumor that the SPA was put back on the table. I just would like to say that nothing else than label could be that (so I just cover the sNDA also, before the new rumor come out “It was not SPA it was sNDA)
Maybe. Just a small correction / “diff.” view:
“If R-IT is negative” - they will officially deny ANCHOR (ANCHOR PDUFA not closed yet)
“If is positive” – they will immediately approve ANCHOR and set-up the PDUFA date for REDUCE-IT
What I will check in, expect from 10-Q tomorrow?
Definitely I will search for SPA / FDA info first and as I wrote it will be “no answer” or “delay” or “no”. (To be fun I will search for “delay” and not for other keyword.)
Revenue: Q1 was 10,967, but “Revenues for the three months ended March 31, 2014 would have been $10.0 million if the Company continued to recognize revenues based on the resale of Vascepa for purposes of filling patient prescriptions and not based on sales from the Company to Distributors” however the revenues would have been 9,264 with the new method due to Deferred revenue 1,703 from 2013. I expect 10,0 - 10,5M for Q2.
COGS / GP% (without KOWA – acc. to accounting standards KOWA fee is part of COGS): Q4 was 59,44% and Q1 was 61,28%. My expectation is 62,5% (COGS: 3,938)
KOWA: It’s impossible to exactly calculate, but I don’t expect more than 500k
Gross Profit: 6,083
R&D: in the range of 10,5 – 11,0
SGA: This is the most expected numbers by me (after Cash-Flow). “the G&A piece of that, excluding noncash items, a little less than $15 million” of 2013FCY, so let’s say 3,750 for every Q. Selling and marketing was 28,274 (Q3) and 22,293 (Q4). Half of the Q4 was with less SF, so I expected 16,5 for Q1, but it was 20,6. I would like to see max. 18,0M now.
Based on these: Operating Income or Loss - -22,9M (or -0,13 EPS)
Notes and Pharmakon payments are 2,4M, so the CF is -25,3M +/- effect of BS items (AR, AP, and Inventory) and non-cash items.
Cash CB: 139M +/- effect of BS items and non-cash items.
FDA never - and will not - put back on the table any SPA for a FINISHED STUDY. btw: usually the Sponsor request the change of the SPA BEFORE START OF OR DURING the study and FDA agree or not)
FDA never - and will not - put back on the table any sNDA if they would like to approve it.
The only thing that could be on the table is Indication / label for negotiation and it's the part of the normal proccess.
Only one thing is 100% sure, SPA had not been reinstated YTD. I’m 100% sure if they receive the YES they will release PR/8-K immediately (if necessary halting the trade).
We could not calculate the exact deadline since not all of the deadline are exactly defined (top of that AMRN could be in the 10% - PDUFA … 2013 THROUGH 2017: Performance goal: 90% of such answers are provided within 30 calendar days of the Center’s receipt of the written appeal)
What we know:
- last decision “in late April” (let’s say Apr 30)
- AMRN has 30 days to appeal (let’s say May 30)
After this too many version and undetermined deadline to calculate the exact due date, since we also know
- “The Official should contact the sponsor within the 30 day window via written response or telephone response (30 day response) ….. Where additional data or input from others are needed to reach a decision on the appeal, the 30 day response should be a description of the plan for obtaining the information (e.g., requesting further information from the sponsor, deciding to schedule a meeting with the sponsor, bringing the issue for discussion at an advisory committee) In such cases, once the required information is received by the Agency, the Official will again have 30 calendar days from the receipt of the required information in which to respond to the appeal and state whether the Agency agrees or disagrees with the sponsor=s stated position.”
- Within 14 calendar days of the Agency’s receipt of a request from industry for a formal Type A meeting, ..… should notify the requester in writing (letter or fax) of the date, time, and place for the meeting, as well as expected Center participants.
- If FDA is unable to complete the review and respond within 30 days, the Official should notify the sponsor, explain the reasons for the delay, and discuss the time frame for completing the review.
but we do not know what’s the exact case:
- AMRN requested the A-type meeting or not
- FDA requested further information from the sponsor, or decided to schedule a meeting with the sponsor, or bringing the issue for discussion at an advisory committee or not
- what is the timeframe of FDA’ action (I could not find exact time frames for “e.g., requesting further information from the sponsor, deciding to schedule a meeting with the sponsor, bringing the issue for discussion at an advisory committee”)
Based on the above the 10-K contains:-
- no answer yet (we are within the 10% or the FDA did not receive the required information) or
- „delay” or
- „no” it’s uphold
We will know it within app. 26 hours or if we are lucky – I don’t think – see a PR/8-K before CC.
These are two different processes:
1) SPA (rescinded)
2.) Appeal - not for SPA only, it's for all topic / decision
I am not a lawyer, but based on my knowledge and experience you could go to court with the final decision only and OND's decision will not be (was?) the final decision.
This is the case in "all" country and for all authority.
Technically not final, but I still think if the answer is no from OND it will not change by higher levels, so I expect a delay and definitely do not expect a yes in 10-Q. (If the answer is yes AMRN will release it immediately by PR and 8-K)
No :(
Re: #31725
Not bickering (but not agreed), see the total picture, it's different situation (it's a second round).
Fair is Fair; But Science is Science
Got it, agreed, (I made the first prediction and % app. 2 weeks ago) so:
The last known date of SPA appeal is Jan 17 (DMEO decision, AMRN 10-Q). With official timeframes (appeal and FDA letter: 30 days, meeting 14 days, weekends) the OND’s answer was due on Aug 1. Of course it’s not 100% correct (based on last 10-Q “late April” – let’s say Apr 30, the due date is Aug 8.)
This week is the “usual” 10-Q week of AMRN and they announced the last 2 event on Monday (Feb 24 & May 9 for event Feb 27 / Thu & May 9 / Fri). I guessed if they announce the event today (case 1.) they got the answer and it’s no, since no 8-K was released.
But they did not announce it and I think it means no definite answer from FDA (and it’s a good sign), so they will wait as long as possible / necessary. The due date of 10-Q is 45 days after the end of the Q, Aug 14.
Top of this they are at the right level – enough, but not too high.
Based on these – and all new “events” (new studies, Senate / Congress, etc.) since ODE II level – I say we have the greatest chance for yes within FDA (not earlier or on higher level).
It’s still possible (40%) that the answer will be no (maybe others yes, but I still do not know the exact reason / rational behind the story and it was rescinded), but I see a good possibility (60%) for other response than no.
I am not sure it will be yes (30%), but at least it will be delayed (30%).
If they announce the event Tue / Wed before any 8-K it’s still a good chance for delay (50%), otherwise no (50%)
I guess they still did not get the answer from FDA. I think it's a good "sign".
Updated:
1. - 0% (previous 2 was announced on Monday 3 / 4 days ahead of event, if they announce it tomorrow - no: 50%, delay 50%)
2.a - 40%
2.b - 30%
2.c - 30%
a.) I said "Yes, but no."
b.) I did not interpreted anything, House and Senate has different wording (directs /encourages) FDA Law Blog
c.) Not guaranted that the new guideline will be different. They could "revise" and re-issue the same guideline (not exactly the same, but for public comment read this).
d.) I could not find any amount on FDALB or in a Bill or House's report, so please help me and post the relevant link
I agree (just check 31586 & 31636 - what's the problem with these?) and I am not pissing matching with him. Still respect his commitment, but nothing will be true due to repeat. It's his style, not mine ... I am just living in the real world and not within mine.
I have only one reason to reflect to his posts: correct / present different view for his statements (never for a fact).
He stated a lot of think (again eg.: 07/28 Label change) which do not have any background top of his fantasy. I could not find any statement from him which was confirmed by fact. To be fair, maybe some of them will be real, but definitely not that time when he said (as I remember the judge ruled the NCE case 2 weeks ago. … Oh, not. It was just a statement from him that the judge will finish the case within a week …).
A lot of people on this board have their own skill and share their view within that range - I never said any statement regarding science since it not my skill - to help others. He is lucky man, since he knows everything, he does not need advice from others, but some people – including myself – need correct info, different view.
And finally, I just wish to be in FDA’s ass, since in this case I know / known what and when is their next step and I could be the richest man in the world.
BB,
Respect, but please read and check twice the topic / issue before post (ie.: 07/28 label change). So,
Updated:
1. - 30%
2.a - 30%
2.b - 20%
2.c - 20%
No, I don’t think that management went into ADCOM with 100% certainty that the vote would be “YES” and I don’t think they are the world best management, BUT I think they did not make big mistakes.
BB & Ladavis23 & Robin F
BB – You are wrong, since
1.) NME (or NCE) does not affect the label
2.) “Manufacturing Change or Addition” never related to exclusivity (or indication)
3.) There is a note: “This supplement type does not usually require new labeling”
4.) It’s related to approval of sNDA (API supplier, a consortium of companies led by Slanmhor Pharmaceutical, Inc.), submitted in August 2013 – It’s not official I read it on YMB, but makes sense for me
Ladavis23:
Patents:
“40, 50, 500 patents, WTF does that mean....NOW??” – It means, that nobody else could register these type of patent NOW. Furthermore: what do you think why AZN did not launch Epanova after 3 months of approval? They don’t have sales force? Or money? No, they did not launch it, since AMRN has the patent.
ADCOM:
“the issue on the table today is whether we should approve something as a surrogate endpoint.” (Dr. Hiatt / AdCom). !!! NO!!! Why not talking about weather forecast … The issue was (not) to approve ANCHOR based on SPA covered trial. Nobody, no other management could be prepared for it.
WS participants LOVE Vascepa but hate AMRN management: c’mon man - it’s a business and not a friendship. If they like the product they will buy it independently from the management. If they hate the product, the management could be the smartest, best, etc. people of the world they will not buy it.
Robin F – No way for bad news AH. IF they already received the answer it will included in 10-Q, but not in press release (just as last time.)
I could not decide. I am interested more in to see:
a.) ANCHOR's SPA reinstatement or
b.) BioBill discussion with a5hi (from YMB)
Why they signed ANCHOR SPA? It was rescinded, so it was useless ... We could wording a lot of "good" question, specially for the past ...
But shortly: yes.
They have only one "real" supplier (Chemport, Inc.) since the first supplier (Nisshin) is more expensive and as you see to get the FDA's approval for supplier is not a short process (it was 11 months).
At the time of the submission BEFORE AdCom it was (and still) reasonable, since all company, in any business has to diverify the sources.
They have minimum purchase levels to enable them to maintain certain exclusivity with each respective supplier (ie.: 2015-16: $27,3M that is with 70% GM is $39M Product revenue for 2 years, easily doable with Marine only).
August 26, 2013
and 10-Q
"In 2012, the Company agreed to terms with a fourth API supplier, a consortium of companies led by Slanmhor Pharmaceutical, Inc."
"We are working with a consortium of companies led by Slanmhor Pharmaceuticals, Inc. to pursue FDA approval for the consortium to manufacture Vascepa API and submitted an sNDA in August 2013"
Technically it's the third, existing supplier since BASF was terminated.
Just read the news and SEC fillings ...
Oh my God ...
FYI: All API supplier should be approved by FDA. Supplier's sNDA not related to ANCHOR's sNDA.
Amarin has an approved NDA (Marine) and they are marketing a product (Vascepa) that is produced for Amarin (not Amarin itself).
This approval effect the P&L form now, since YTD all purchase from Slanmhor was booked as R&D (Cost / P&L) and will be as inventory (Balance Sheet).
I read several times.
Could you please, mark anything in the new guidance (...Fixed-Combination Drug Products) that is new and applied by FDA for Vascepa?
As I know V is not a Fixed-Combination Drug Products ... (yet ... )
Amarin said: "FDA must continue to apply its past policy that the active moiety of a complex mixture is the mixture itself until FDA revises that interpretation of the applicable regulations through notice-andcomment rulemaking" - I could not find any guidance refers to it, so it was "just" a practice
But again, the real issue is moiety vs ingredient and this is AMRN's favor.
picasel: FDA could deny NCE EXACTLY with the same reason in July 2012. My view: it's not related to the new guidance above
picasel,
No, you misunderstand.
- FDA did not said that the ingredient the same, they agreed these are different.
- "new policy": I think it's better to call interpretation. The issue is here the one-to-one or one-to-many relation (regarding ingredient-moiety). As I understand: Amarin challanged the new interpretation of this in case of naturally derived mixture. (My opinion: FDA has right). So as I see no new policy issued by FDA, they applied a new method to analys Lovaza.
The issue is the moiety, but this is exist only in FDA's CFR and not in the USC (statue is about ingredients) for NCE determination.
I did and I think Amarin did not refer to the new Fixed-Combination Guidance, since it’s not relevant to Vascepa.
They refer to the new policy / interpretation of active moiety of naturally derived mixture (one-to-many instead of one-to-one). I could not find any policy or guidance which dealing with this and I think FDA has right, since EPA is definitely an active moiety in Lovaza, HOWEVER it’s not relevant for NCE determination, since moiety is “just” an interpretation of the statue by FDA. As Amarin said: “FDA has improperly substituted the words “active moiety” for the statute’s words (“active ingredient”).”
FDA was always consistent to decide NCE based on active moiety, however it was rejected by court several times as the statue (USC) is stronger, higher level than CFR.
I do not know when, but the final court ruling will grant the NCE status to Vascepa for the period 2012 – 2017 based on statue and previous decisions.
No. It's not related to usage, indication, etc. It's irrelevant, meaningless info.
It's a manufacturing 'change'. I guess they just change the design of / info on the carton. (just like on 02/26/14, 11/25/13)
NCE and SPA: these will not change the label
sNDA: if approved it will change the label, but we will know it before label' change ...
We know:
- minimum number: 1.612 events
- interim "date": at 60% / 967 events
but we do not know the prespecified stopping guidelines in the DMC charter.
At any interim analysis (planned or not) the statistical significance should be strong enough and the findings should be consistent when the components of the primary end point evaluated individually
JL,
Please check / comment this:
We - including myself - used the 5,2% as the event rate of placebo arm, however I could find it only as the overall event rate for the study (ie.: Amarin Presentations for the October 16, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee page 73). If this is the case, then the planned placebo rate is 5,62% and the Vascepa arm is 4,78% (avg. 5,2% with 15% eff.).
The lower than expected total events rate (resulted in design modification in May 2013) due to:
a.) lower event rate in placebo: assuming that “number is calculated by actuaries and takes into account whether they are primary or secondary interventions” it’s not the case
b.) Vascepa is significantly better than 15%.
We don’t know the exact difference, however if the actual rate was (before May 2013, for the total trial and assuming that placebo arm was 5,62% as planned)
5,00% (96% of 5,2%) = 22% eff.
4,94% (95% of 5,2%) = 24% eff.
4,68% (90% of 5,2%) = 34% eff.
I found the answer (?) for my own question:
"Special circumstances may dictate the need for an interim analysis that was not defined at the start of a trial"
and I guess high eff.% could be called special circumstances, so interim analysis could be done and if meet with stopping guideline the DMC will propose to stop the study.