I like it:

"I don't need EPA to cure my dry eyes. Looking at the stock price alone is enough." ((c) VascepaBid / ST)

Assuming that average patient get a script for 3 months, TRx = weekly NRx + 1 months ago NRx + 2 months ago NRx. In case of established drug - flat NRx - these are 1/3-1/3-1/3, so weekly NRx is 33%. As V is in growing phase weekly NRx will be "always" higher than previous months NRxs.

It looks like avg. 70% (weekly refills / 1 months ago NRx + 2 months ago NRx) refills their script. Last week was also affected by previous week (week after TG week) since that week was overloaded w refills. (TG week was 65% and the next week was 75%. This week was 68%).

It's trending in the right direction (as NRx), since last year was below 60% refills only.

My prediction for this week:
NRX: 4,652
TRx: 10,473 (4,652 + 70% of 11/14 week NRx + 70% of 10/17 week NRx)

Do not forget: these weekly numbers are extrapolated from the 70% of the total universe by Symphony Health. These are not real numbers, just best guesses.

Sometimes the simplest answer is the answer:

FDA approved Trilipx and Niaspan for "ANCHOR" with a hope that they reduce CVE. After the outcomes trials they recognized that their expectation were not only wrong, but serious side effects are exist. They were frightened and rescind the SPA to avoid the same situation w Vascepa.

Meanwhile a lot of study support V's efficacy we do not have a proof and we do not have a long-term safety follow-up (top of the 2 years marketed period, but it is not the same as the R-IT safety follow-up).

We are "lucky", since they did not act immediately, just by the end of 2013. We could hope that:
- ANCHOR data will be on label
- maybe (if Committee means anything) FDA will approve ANCHOR with a written commitment from AMRN to finish R-IT and apply the new policy for new SPAs only

However as the time is passing ANCHOR (just like NCE) will / could be less and less important, since R-IT interim result is around the corner. Of course, any type of ANCHOR will be good since it could help to reach the interim, however more or less not enough time left till R-IT interim to fully monetize the ANCHOR market.

BB-

We could say that all issue were managed by the same way (FDA's bad faith / corruption / nonprofessional - ebody has to choose his own), however regarding NCE / ANCHOR / R-IT none of them has an effect on the others.
ie.: NCE ruling won't determine ANCHOR or R-IT decision or ANCHOR decision won't affect R-IT sNDA / approval.

The relation is the sponsor (AMRN) and the authority (FDA) only, nothing more.

It's not a question that FDA was wrong regarding ANCHOR SPA and (hopefully) about NCE, but "at least" they have some (bad) logic behind this (no evidence / active ingredient isn't equal w active moiety).

I hope I am wrong, but I think that their view (evidence is required) about SPA won't be change. We can hope (since they did not act in time), but it looks unlikely.

The main issue is the timing of their action and not the action itself. Just imagine: if they inform AMRN immediately after Trilipx's AdCom, we are in the same situation w/o any hope of "compromise". (Again, the current stage of sNDA is not a negotiation. FDA will issue an approval or a CRL or a CRL w recommendation. AMRN could submit proposals, however FDA won't discuss it with them.)

NCE isn't a slam dunk, however I am optimistic. I do not care how FDA determines moiety and how they determines NCE, since FDA agreed w AMRN that the active ingredient is new / unique (diff. from Lovaza) and the statue is about "active ingredient". FDA and AMRN are equal at the court. They have different view on NCE, however AMRN's based on statue, meanwhile FDA's based on their own regulation. If the Judge will rules as in previous cases: NCE will be granted.

Oh yeah!
Or maybe if they have a sunny days or wife / girlfriend was nice with them they will approve R-IT now w/o result and sNDA ...

Meanwhile, It's normal that AMRN is in our focus - it's AMRN board - it's just one drug for the FDA. They are not people, they are office: no emotion, no logic.

No question, they were wrong w SPA rescission and I think that they were wrong w NME. However, these were not decided based on emotion or corruption. The situation is worst. They were wrong.

NCE will be decided by the court and it won't affect anyway - nor legally, nor emotionally - the SPA / sNDA.

SPA: I do not expect the reversal. Maybe the Committed will say that FDA was wrong technically (timing), but they won't reverse the decision itself.

sNDA: I see a good chance for ANCHOR's data on label - as best case scenario - but nothing for approval. meanwhile a lot of study support it, none of them confirmed. That's it. FDA did not say it isn't effective, they said: we do not know and it's not an AA.

Don't expect a miracle, a short-term solution. It's 16 months ahead. During this we have to see: increase in script#. Depends on this increase AMRN could reach the interim result w/o external financing.

BB,

I agree that generic suit and NCE suit could be linked. (If NCE granted generic suit will be dismissed).

However, no relation between:
- generic / NCE and SPA
- Anchor and R-IT

Furthermore ANCHOR's SPA or sNDA is not necessary for R-IT's approval.

Agree.
More "interesting" is the decent increase w avg. volume before the housekeeping.

AMRN isn't S&P 500 component

Yes, they got the early warning, however as they track the index, usually / most of them restructure the portfolio as near as possible to the date of the change (Monday, Dec 22).

Yes, the AH was 2M+, but was an additional 2M+ in the last few minutes

(Meanwhile part of the volume could be tax-c-f also, I do not think that was significant since the last day for it is Dec 24.)

If you have a persecution mania, does not mean that you were not tracked. However, we have to separate “what” and “how” was done by FDA:

SPA:
- meanwhile their reason is more than questionable, they have every authority to rescind the SPA
- it isn’t a question that FDA did not act in expected manner

They committed – at least – a technical error / mistake, did not notify the sponsor of such issues within a reasonable period of time after FDA becomes aware. (Maybe) we will get an answer / solution within 60 (57) days. My view: the “technical” mistake is not enough to reverse the decision.

NCE:
- their action was false (ingredient vs moiety, mixture vs combination)
- the process length – 18 months – was a joke

My view: Based on previous cases (some of them USPTO) NCE will be granted. (I won’t be surprised if the “generic” case will be delayed till NCE ruling)

Structurally Similar Drug with Different Biological Properties Meets Criteria for Term Extension

CONFUSION PERSISTS AROUND DRUG EXCLUSIVITY AND PATENT TERM EXTENSIONS FOR NEW CHEMICAL ENTITIES

sNDA:
- we still do not know the decision, however it looks like that the best case scenario will be the ANCHOR data on label
- the process length – 20 months YTD, 12 months overdue – is unacceptable. Meanwhile the sNDA and the SPA’s appeal were two different process, I could accept that no sNDA decision meanwhile the appeal was ongoing, but no excuse since September.

My view: They will not act till answer to Committee or they make a U-turn and give a full approval (unlikely).

The high volume wasn't a surprise, since AMRN will be excluded from NBI by Monday. It means that ETFs, that track NBI, close their AMRN position. However,
- the 2/3 of the daily volume was in the last few minutes and AH (more than 4M)
- usually this type of trade puts a pressure on the pps, but not this case (more exactly: it was, but could not eliminate the earlier gain)

My view: it was a nice gain (+$0.15) with a little bit above average volume (app. 2.5M vs 1.9M) and the -$0.07 and the +4M volume aren't interesting, since these were technical and not fundamental. Furthermore the demand for this 4M could be a positive sign.

Really?

Rennaisance could profit more from AMRN than lose on GSK.

GSK 5 years min. is $30 (lower by 30% as of today).
AMRN 5 years max. is $20 (higher by 2000% as of today)

Keep it mind this is the 2nd test. The first was approved in 2003 (note the bold ...):

Mon, 21 Jul 2003

San Francisco, CA - The FDA has granted market clearance to a lipoprotein-associated phospholipase A2 (Lp-PLA2) test for coronary heart disease (diaDexus Inc).

The test, called PLACTM, is marketed as a way to identify patients at risk who do not have elevated LDL levels. Results from the ARIC study, presented by Dr Christie M Ballantyne (Baylor College of Medicine, Houston, TX) at the American College of Cardiology 2003 Scientific Sessions (and reported previously on heartwire ), show that individuals with normal LDL but elevated levels of Lp-PLA2 are roughly twice as likely to experience a coronary event as those individuals with normal levels of both LDL and Lp-PLA2 and that the risk is even higher for patients with elevated levels of both Lp-PLA2 and CRP.

"Receiving marketing clearance for the PLAC test represents an important milestone for diaDexus," said Patrick Plewman (diaDexus) in a press statement. "There is significant market potential for a product that helps identify patients at risk for CHD who are not currently identified by traditional risk factors."

According to the company, research is currently under way to evaluate the effects of statin therapy on Lp-PLA2 levels. In addition, GlaxoSmithKline is developing an inhibitor to Lp-PLA2 as a potential treatment for atherosclerosis. This inhibitor is currently in phase 2 clinical trials.

FDA approves Lp-PLA2 test for CHD

It is in FDA's BD also.

Don't be silly: STOP IT!!!

I am still believe:
- from script#
- from other source (but not dilution)

Let's see the next 6 months.

Basically 3 question are remaining:

- R-IT will be stopped based on interim (90%) or final (10%) result?
- BO will occurs before (10%) or after (90%) result?
- How many share will be outstanding at the time of BO?

Let's assume 100% dilution ( I do not think) resulted in 500M shares. With R-IT the company will worth at least 5B (!10 / shares), so I do not care dilution ...

AMRN said that the end of the study expected by end of 2017. Based on my calculation it means 23-31% eff.

60% (for 23-31% eff.) is Jan-Feb 2016.

To stop the study at interim ((c) 2013&2014 Biwatch):
- "if Vascepa shows an efficacy >19.5% at the interim analysis, this should be sufficient to have a p-value <0.001 and then to stop the study early for efficacy."
- "If the efficacy is 25%, the power would be 99%, and the probability of stopping the study at the interim analysis would then be very high."

ps.: as I wrote we will solve the shipping issue, as I will be in Houston in Feb 2017

I could agree w JL re 50% eff. Why not? However DMC does not have a opportunity to look the data before the 967th event. Ergo, never-mind it is 100% or 0% eff. it won't stop before predefined interim analysis.

But to be clear, I hope, I am wrong and it will ...

2 a.m. Central European Time (normally +6)

My view:
967th event: Jan-Feb 2016
analysis duration: 2- 4 months
release: Mar - Jun 2016

To be "exact": end of April / beginning of May (before or with the Q1 result) 2016 (Apr 20 - May 8 2016).

It looks like we are at the beginning again: you raised the same thing several months ago.

a.) AMRN definitely stated that they did not go for CVE reduction
b.) If they request - let's say - "lower TG in 200-500" (and nothing more), we would see the same result, since the "problem" is the TG level / range and not the requested indication. Dr. Hiatt / AdCom: "I appreciate that. I'm still just wrestling a little bit with -- 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. ... So the only reason to treat these mid-range triglycerides is to prevent heart attack, stroke, and death."

Thx.

Let me rephrase my question, "my worry":

If it will be accepted by the Senate and House the the 60 days will be started or not? Since it is CRomnibus and not a normal Budget / Bill.

No deferred revenue, since they are not (ac)counting that anymore.

- I said / think they will "overdeliver" (as in Q2) by "the first week of 15"
- wholesale price was increased by 7% late November

My current prediction is: $18,4M ... but I will update it based on the next 4 weeks script#

If somebody missed it:

AMRN increased the gross price by 7% in late November, it is $208-209 now. (I am using 208,69).

For net, I am using (from Q3): 25,92% Trade Allowances & Rebates, Chargebacks and Discounts + 0,5% product returns + 7,44% other incentive = 33,86% (33,5% for Q4 and 33% for Q115 and forward as Other incentives are ABS number and not %).

As they increased it late November it will affect Q4 also. Let’s say 9 weeks with $195,04 and 4 weeks with $208,69.

I have scenario for Q1, but do not want to project anything, since it looks like that something is happening with scripts:
- this week # isn’t just back to 2-weeks-ago level (as last year), but higher
- TRx / NRx ratio is tending in the right direction since June (especially during the last 4 weeks)

However, few weeks data isn’t a trend, so I would like to see the next 8 weeks to update my forecast.

Sit down and fasten your seat belt ...

From FDA's BD:

Will the 60 days clock (answer to Committee) start to run today or not? Any thought?

AMRN did not go for R-IT label / CVE reduction.

From AdCom:

No, it is just accounting.

The total remaining cash payments due on this debt are $145.8 million by 09/30, $144.4 million as of today.

39821

Welcome in the club! It was public always, just some people thought that the requested indication includes claim of CV risk reduction, meanwhile not .(Trilipix and Niaspan has more or less the same label for 200-500).

I had a dispute about it with one iHub poster (I do not remember his name. It was something like 3 letters and 2 numbers ... )

Ajax,

It's not a perfect example, but:

If somebody stole your notecase, come back 10 minutes later and ask you to sign that it was gift from you: do you sign it?

It looks to me that FDA would like to "cover" their action.

Best,
G

ps.: care your keyboard, your CapsLock is wrong.

Thanks.
As it was ANCHORS's SPA, final questions:

Ajax: Thanks.
Just for clarity - Is SPA means ANCHOR's or REDUCE-IT's SPA?