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Mr. Rosenman has nearly 15-years executive experience in the health and wellness sectors, including weight loss, cosmetics skincare and nutrition, both Rx and OTC. Expertise areas include strategic market and product planning and corporate development (evaluation, recommendation and execution of... More
  • Today's Non-Move By FDA Tells Us One Thing... 71 comments
    Apr 12, 2013 12:58 PM | about stocks: AMRN

    I will come out and say up front, this post is not to try and spin a non-decision by FDA on NCE status - there is no good way to look at FDA delaying so much, nothing good has or will come out of that, to be clear.

    But, today's non-move actually does help eliminate one theory (which, while I did not agree with, I certainly felt had some merit and needed to be considered)...the timing of the generic Vascepa guidance *could have been" taken as that a decision was made that Vascepa is not NCE. If so, the answer would have been handed down and updated in the OB today as a "no". That has not happened, so that negative theory around the generic guidance timing is no longer out there.

    Rather, I believe that guidance helps the case for NCE - but I have already discussed that on another post and that is a issue separate of today's OB non-event.

    Stocks: AMRN
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Comments (71)
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  • Pirateescapee
    , contributor
    Comments (111) | Send Message
     
    I really don't think NCE is that big of a deal at this point. The NCE "watch" has become tremendous drama for those who trade each and every event/catalyst for .50 to 1.00 dollar swings. For investors I think acceptance of the sNDA for ANCHOR, a good trajectory on script growth ( which also factors in Tier 2 conversion success) and last but certainly not least a clear commercialization plan for the ANCHOR indication, trump NCE. If Joe Z. fiddle farts around and doesn't articulate clearly and definitively the commercialization aspect, he will have done shareholders a big disservice. With 19 patents and/or NOAs and 30 pending applications I don't think NCE is the hangup for institutional investors or BPs. I just think that there have been numerous failed drug launches by biotechs and when Joe Z. decided to launch alone, he bought the BPs time to sit back and watch. The time to sit back and watch will wind down if the launch proves successful, the sNDA is approved and we get closer to a PDUFA date. Sometime soon both Joe Z. and the BPs will have to fish or cut bait.
    12 Apr 2013, 03:56 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Monday is April 15th we are less than 10 weeks away from combo data. I would guess they will be a month early as Amrn has always beat previous guided results. So we can count on 6 weeks. We will also have the response to the SNDA within several weeks as well. Off course 2 more FDA updated by June as well. Just one of these events can put us back into double digits. Not to mention at some point the scripts will have to be noted. Even if we only rise 200 scripts every week by the end of the year we have a run rate of 130 million per year. Off course this is super conservative as me move towards tier 2 coverage from all the scripts will gain momentum. I was in AMRN the spring when we jumped from 8 to 16 on that Monday. Not saying it will happen again but things can change for us in one week. Patience will pay off.
    12 Apr 2013, 09:27 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » good point DNDN
    12 Apr 2013, 09:56 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » for the record everyone:
    1) i have said i will always delete this 'stephenhandals' posts and will continue to do so, he has lost all privaledges on commenting
    2) i dont participate in any other message boards, so beware if people are claiming to be me anywhere else. i only write on SA, and get no compensation for it.
    12 Apr 2013, 07:32 PM Reply Like
  • jasonturbo
    , contributor
    Comments (6) | Send Message
     
    I don't understand how the OB has been updated when the website for the FDA still shows it as only being current to Feb 2013..?
    15 Apr 2013, 07:51 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » OB says March, it is updated
    15 Apr 2013, 12:24 PM Reply Like
  • jasonturbo
    , contributor
    Comments (6) | Send Message
     
    I meant at the time, when I originally submitted that post it was Friday around Noon ET, the OB wasn't actually updated until roughly 2PM ET - yet somehow people knew already knew what the March OB update included.

     

    There is another source from which this information can be determined, and it seems to be slightly faster than the online OB update.
    15 Apr 2013, 06:15 PM Reply Like
  • voltnfan
    , contributor
    Comments (5) | Send Message
     
    What are the script numbers reported this week?
    15 Apr 2013, 10:10 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » properly refreshing the OB page is the quickest and most accurate. thanks
    15 Apr 2013, 09:23 PM Reply Like
  • exp456
    , contributor
    Comments (38) | Send Message
     
    I am getting really stressed! Have a $14 cost basis.

     

    If the scripts aren't growing at a high rate, should Zi just call it quits and sell with a loss, Steve????
    15 Apr 2013, 10:17 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » If you read my articles/research and are in my camp, you would hold and accumulate until $25+.
    15 Apr 2013, 10:48 PM Reply Like
  • stephenhandal
    , contributor
    Comments (185) | Send Message
     
    $25+ now? You were saying high $30s months ago, even low $40s at one point. Then that price dropped back to mid $30s, then $28-32 and now you're claiming $25+??
    16 Apr 2013, 09:41 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » $25+... meaning more than $25. A value greater than $25 dollars... A stock price of higher value than twenty five dollars.. If you had 2,500 pennies, that would not be high enough, because it is PLUS, more than 2,500 pennies, so while 2,501 pennies may do it, its more likely to be 2,800-3,200 like I've said all along. You clear now smuck?
    17 Apr 2013, 12:14 PM Reply Like
  • stephenhandal
    , contributor
    Comments (185) | Send Message
     
    Don't worry I got a good comeback for you. Just wait
    17 Apr 2013, 01:17 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » Great, the delete button is just waiting.
    17 Apr 2013, 01:57 PM Reply Like
  • DNDNLONG
    , contributor
    Comments (116) | Send Message
     
    Stephen,

     

    You need to work harder since you only have one follower. It seems nobody values what you have to say. We used to hear the same bs over the patents issues....Why dont you argue about how AMRN will never get one patent etc etc..Whatever happened to those arguments. You guys just keep drawing new lines in the sand and soon enough you will argue how stock will never hit 50 after it hits 25.
    17 Apr 2013, 05:13 PM Reply Like
  • gtgtbangbang
    , contributor
    Comments (100) | Send Message
     
    thanks for illuminating that handal,

     

    I thought Steve's pinky rung up a '+' instead of a '0'
    18 Apr 2013, 01:23 AM Reply Like
  • stephenhandal
    , contributor
    Comments (185) | Send Message
     
    DNDNLONG:

     

    I never made this connection, but you must be 'bullrunner' from ST. How can you make an inference that "it seems nobody values what you have to say" by just looking at the number of followers? Do you really think I care how many followers I have? I don't have a big, strong ego unlike many Amarin longs and I look at both sides. Then you state "you guys" - what are you grouping me as a short? Don't be one-sided and blind to other views. Look at everyone's. perspectives. I don't write sensationalism on Amarin and stuff like that so that most likely explains why I don't have a lot of followers, unlike some on SA. You think I'm a short and what not just based on some of my statements, yet that shows how you're only superficially reading into what I say and don't know me well enough.
    1 May 2013, 12:24 AM Reply Like
  • exp456
    , contributor
    Comments (38) | Send Message
     
    Mr Handel- what does the plus after $25 imply???

     

    Lets think about it!

     

    You're like a bad fungus that keeps coming back.
    16 Apr 2013, 09:58 AM Reply Like
  • fiddlerpaul
    , contributor
    Comments (2) | Send Message
     
    Steve, just wanted to throw in a comment of appreciation for your knowledge and insight. I sort of fell into investing with AMRN last year and have watched the roller coaster unfold. Your posts have been rock solid and cut through so much crap for me. Thank you.
    17 Apr 2013, 06:41 PM Reply Like
  • exp456
    , contributor
    Comments (38) | Send Message
     
    I just hope all of us longs did not overestimate the demand.
    17 Apr 2013, 06:44 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » All about Anchor my friend.
    18 Apr 2013, 09:19 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » nah, just watch the fundementals...only changes have been for the better (IP)
    17 Apr 2013, 08:03 PM Reply Like
  • exp456
    , contributor
    Comments (38) | Send Message
     
    Thanks Steve. What I also seem to worry about is the possibility of dilutive financing if there is no partnership.
    18 Apr 2013, 03:51 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » not going to happen anytime soon - you see the financing instrument that mg't took with marine launch and there is a reason for that...they don't expect long-term need for capital.
    18 Apr 2013, 05:22 PM Reply Like
  • golfstud
    , contributor
    Comments (52) | Send Message
     
    Steve I have been reading alot of comments on yahoo that the script numbers have been slowing down while lovazza numbers have increased. Do u agree with that assessment? Also do u feel that Amarins launch of vascepa has been slow or what u expected? If things chug along as they have will the company have enough cash to make it to 2014? A lot of questions but curious on your thoughts
    18 Apr 2013, 08:31 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » vascepa's launch has been as expected in my view...on track to meet SP of $12-15 for just the marine indication, or value the company at around $2-3B. with only a few months data, not a good indicator yet - but i'm not concerned about marine really, it all about anchor. if they dont partner/sell out on anchor, then the concern the market has now, would be legit if marine has not been built. i believe the co. is $6-10B on anchor.
    18 Apr 2013, 09:57 PM Reply Like
  • golfstud
    , contributor
    Comments (52) | Send Message
     
    want to clarify a few things regarding pps. you have said many times your price target is $28-$32 but per above if marine worth $2 to 3 billion or $12-15pps and you feel anchor worth $6-10 billion then per those numbers price per share is more in the range of $36 low end to $45 on the high end, correct?
    19 Apr 2013, 09:44 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » Yes, you are correct in general, but you do have to add some costs and overhead in to get there, so I was being a bit more conservative. Your numbers would be more applicable for BO. $28-32 could be for BO <OR> would allow for partner/dist. agreement or go it alone.
    19 Apr 2013, 09:55 AM Reply Like
  • golfstud
    , contributor
    Comments (52) | Send Message
     
    please give me the scenario's that you think play out with amarin in terms of time frame with pps if they partner or are bought out. could we be looking at a $30 plus pps by end of this year??? thanks
    19 Apr 2013, 07:17 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » i dont like commenting too much on time frames, but yes - the major move should occur this calendar year
    19 Apr 2013, 07:31 PM Reply Like
  • sblfe
    , contributor
    Comments (14) | Send Message
     
    Good post. This is worth having a good discussion on. My understanding also is that a significant portion of Lovaza's sales are off-label in the Anchor indication. I do believe that some of the longs are overly bullish on Anchor and simplistically assuming that a market 10x the size should yield 10x the revenue. Obviously we know that is not true. Assuming your number for off- label use is correct at 50%, we are talking about peak 500mil in both Marine and Anchor using today’s Lovaza numbers. I think we can correctly assume that if marketed properly, market share should easily be taken in the marine indication from both Lovaza and Niaspan as V is clearly clinically superior. On the anchor side, ALL of the Lovaza usage should move over to V- I believe the health coverage providers rapid move to tier 2 for V indicates this.
    Simplistically and conservatively assuming V can get 1.5x Lovaza’s current take (assumes taking market share from Niaspan also) in the marine indication (500x1.5 = 750m) and also expand the usage in Anchor 2-3 fold (500m x 2 or 3= 1bil or 1.5bil) Lovaza’s current take. We arrive at peak sales at 1.75bil to 2.25 bil. This would be my lowball estimate since I believe Anchor could ultimately garner much more than 1.5 bil. With 2bil sales potential, I’d say the company is worth at least a 1.5-2.5x sales multiple. That would mean 3-5 bil. Still not bad….
    19 Apr 2013, 03:46 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » The off label use of Lovaza is the biggest misnomer and those who tout that as competition to Vascepa on Anchor have absolutely no clue what they are talking about (stephenhandal type of comments). You see, while it may be used 'off label' now because there is no other available therapy approved by FDA for that indication, in most cases, if covered at all, it is at high insurance tiers. First hand experience example here: I was given a script for Lovaza due to high 270-325 level (not very high TG) last year, prescription would not be covered and I have good insurance. Cost to me would have been $80-90. I am now waiting for Anchor, so I can get coverage. With anchor behind, we are talking billions. Shame on Amarin should they choose to not fully maximize the opportunity by passing on big pharma marketing/distribution - but if you are smart and you see the direction they are going w/ Reduce-It, you would know that's not the overall plan. Plan is to attract a cardio focused big pharma and maximize company value. You listen to me, I believe they'll do it. You listen to others like AF, they don't-- although I will say if you screen out AF's BS and apparent attraction to me, he has ratcheted down his rhetoric and seems to be giving AMRN a wait and see chance now.
    19 Apr 2013, 08:56 AM Reply Like
  • stephenhandal
    , contributor
    Comments (185) | Send Message
     
    Steve, did I ever directly say that Lovaza was competition to Vascepa on ANCHOR? Absolutely not. Get your facts straight. Also I said that I didn't know if the statement was true or not so relax. Why can't we have a conversation here? All I'm saying is I don't understand why people are saying doctors have to wait for ANCHOR to be approved to prescribe to the 200-500 TGs - people can go get a Vascepa prescription now, although it may be more costly. Scripts need to pick up seriously
    19 Apr 2013, 09:46 AM Reply Like
  • sblfe
    , contributor
    Comments (14) | Send Message
     
    Hey Steve- I agree completely on the off-label use and the fact that Anchor will take all of that market share. The issue I have is the common misconception that Lovaza's 1bil sales came all from the marine indication. I recall Joe Z mentioning the heavy off label usage of Lovaza also so there has to be some truth to it. In sum, all i'm saying is that the Lovaza's sales in the marine indication is less than their 1bil sales figure...

     

    If the reduce-it study came back positive with results even close to Jelis, V would become one of the biggest drugs of all time. I don't think we will ever see that day with the company as a stand alone company. Hopefully there are some contingent payouts associated with any buyout so that we can participate should Reduce-it prove positive.
    19 Apr 2013, 07:17 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » fair enough.
    19 Apr 2013, 07:32 PM Reply Like
  • stephenhandal
    , contributor
    Comments (185) | Send Message
     
    I don't think we'll have Reduce-it results till 2015-2016, right? That's a ways away. Is there a chance the company will provide results/data on the current progress for the Reduce-it trial?
    19 Apr 2013, 10:41 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » Yes, company recently stated that interim results will be reported, and this is typical, so we would have transparency there.
    20 Apr 2013, 09:16 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (76) | Send Message
     
    Steve, first of all I would like to thank you for all your work.
    I think everybody would like to read some comments about the current pps. What do you think is happening? In my opinion, market is preparing the price to launch a large accumulation of cheap shares (at least -50% discount), as soon as first good news are known. We know there are several big catalysts in front of us but maybe the only one that can move the pps is NDA acceptance because after that the odds of approval are very high.
    That's the reason because I think that the current pps is just a complete market manipulation and this kind of tactics are very well known for all of us who invest in biotechs. Thanks again and regards ( from Europe, we are a legion of investors ).
    20 Apr 2013, 06:18 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » I believe its funds, nothing to do with fundementals or any news that is being hidden, nor the individual shorts. This does suggest, however, that the large funds believe there is more time where they can make money elsewhere than in AMRN, for now. If the "big" catalyst is FDA approval for Anchor, they would be right since its later in the year. Everyone has given up on guessing time for NCE and the only other extreme catalyst (no less than 100-300X from where we are now) would be BO rumors.offers. Just my take, Im not an expert in this field but have first hand knowledge of how the institutional investors behave, from being a sr. mgr at public companies in the past. They turn investments more than a doorknob if they can make a buck.
    20 Apr 2013, 09:20 AM Reply Like
  • Scientist on Stocks
    , contributor
    Comments (416) | Send Message
     
    i don't know the source of the 'theory' that sees relationship between timing of generic Vascepa guidance and NCE denial, i believe it makes no sense.

     

    What made you to feel that it had 'some merit and needed to be considered' ?
    21 Apr 2013, 10:35 AM Reply Like
  • exp456
    , contributor
    Comments (38) | Send Message
     
    Hi Steve-

     

    Can you please respond to these 2 posts that akanz2 on the YMB wrote?
    Post # 1
    Do you have any information on what BASF is doing in Europe with Pronova. They had stated they intended to move into high quality dietary supplements .
    Not bashing folks ....I hope all you longs become fabulously wealthy ....but as you know Amarin has the patents for greater then 90% pure EPA devoid of DHA .....but 90% and lower pure EPA has been in the marketplace for yrs.
    If Reduce it shows clinical benefit then IMHO the threat is not from generics but cheaper DS alternatives .
    Amarins coupon program expires end of 2013 I believe.
    Just my thoughts ....don't mind if I am wrong
    AK Less

     

    Post 2

     

    Good pts --- but BASF now controls one of the largest producers of highly purified fish oils ( Pronova )---- certainly the largest for an FDA approved extract from fish oil , product ( since they supply Lovaza to GSK )

     

    The statin /EPA combo pill is likely years away if ever IMHO -- a few of the problems are 1) you take statins at night for max effect but EPA is half am / half pm ...so how do you dose it ( different colored pills ? )
    2) The strongest statin is Crestor but some find they are more prone to cramping and need less potent statins , so who do you combo with ... and so on ..so Not sure how feasible it is .

     

    Guess what I'm thinking is that if Amarin were to announce an alliance with BASF ( beyond what they have with Equatech ) to develop product for the Anchor indication I would be more enthusiastic ... until then I'm skeptical.
    There are many moving parts here , but an important one is who controls most of the supply of purified EPA because if Reduce it shows clinical benefit --- purified EPA that will likely be in high demand.
    AK Less
    21 Apr 2013, 08:35 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » Not sure exactly what you are asking?

     

    If you are guessing BSF will be targeting high margin Rx fish oil for AMRN you would be right.
    22 Apr 2013, 09:29 AM Reply Like
  • golfstud
    , contributor
    Comments (52) | Send Message
     
    Steve what chances do you give that reason of approval is granted for anchor within the next 2 weeks or so? If granted does that pretty much guarantee we receive notice of approval by years end?
    22 Apr 2013, 02:40 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » Approval for sNDA and approval for indication are different. I know you know that, just want to be clear for any other readers. They are two separate events, first one means that the method AMRN is asking for to get the indication approved is agreeable to FDA. Second is the nod that the drug is safe and efficacious and that is can be marketed. They are judged separately. In this case, my view is approval of both is as close to 100% as you can get.
    22 Apr 2013, 09:32 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (76) | Send Message
     
    about ACCEPTANCE
    "... Assuming that everything is found to be acceptable, the FDA will decide if the NDA will get a standard or accelerated review and communicate the acceptance of the application and their review choice in a communication known as the 74-day letter ( from 02/26/2013, that letter could be received by 11th May ).

     

    about APPROVAL
    A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months..."

     

    So, 10 months from now is Feb'14 and 6 months is Oct-Nov'13

     

    is this correct?
    22 Apr 2013, 06:32 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » More or less. From the horrendous NCE situation, we know not to hold FDA to any dates ... but Anchor should go in our favor and be an explosive catalyst from time sNDA approved through Q3 if AMRN not acquired by then...
    22 Apr 2013, 09:33 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (111) | Send Message
     
    Not to start up another SR vs AF argument but do you have any comment on his latest assertions? He is known for quoting unnamed supposedly industry related sources that quite often are wrong and the timing is usually suspect as well. Normally I would say that there are interests involved in trying to keep a lid on the PPS, however the volume would indicate that there is no reason to do so. The total lack of institutional leadership at this juncture is alittle concerning and the short interest ever increasing. Sometimes you have to invest or trade on what you see as opposed to what you think you know. I do know that the time period between filing an NDA and the PDUFA date can be a time for shorting and then a brief run up but in this case we seem to be dead in the water. What is it that we don't know or are missing?
    22 Apr 2013, 10:48 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » His "investor source" is his alter ego, I'm sure. He clearly knows nothing of the exclusivity process or what the requirements are. FDA would never issue NME until NCE is determined, which at this stage, it is not yet. Ultimately, patents protect longer and stronger.

     

    He also conveniently doesn't mention patents. A more accurate article would have been titled, "AMRN's exclusivity story has been improved with strong patent portfolio".

     

    Nice that he didn't mention the increasing scripts and the revised monthly script data that shows steady increase, even for week prior. But as I've said, that doesn't mean too much, given Anchor, not marine is the compelling reason to follow AMRN.

     

    At this point, the way AF is going, when AMRN receives approval for Anchor and the stock is at new highs, I'm sure AF will issue an attempted bash pieces, and like usual, nobody will take him seriously.
    22 Apr 2013, 10:57 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (111) | Send Message
     
    In fairness he did mention scripts albeit with a negative slant. Putting all that aside given his bias, what troubles me is the lack of institutional sponsorship here. Makes me uneasy because I can't explain it. If it simply due to waiting on the sNDA acceptance, great. A lack of volume and PPS increase beyond that is IMO of great concern. The market is pricing in failure on multiple fronts @ 6.80 ish.
    22 Apr 2013, 11:25 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » I understand and agree - hard to explain a $20+ stock (given Anchor) trading at current levels. However, if you look at history with AMRN and its price movements upward, then followed by sell offs, the lack of big funds doesn't surprise me now. They move money in and out dependent on timing of catalysts. AMRN being a one-wonder drug is not a buy and hold for long haul (5+ years). Its one to invest in due to a particular asset, tied to catalyst, in this anything positive related to Anchor.
    22 Apr 2013, 11:52 AM Reply Like
  • bravo33
    , contributor
    Comments (62) | Send Message
     
    Steve,

     

    Can you explain from your experience the interaction between financial analysts who rate stocks and major funds that invest? Is there a strong, medium or weak relationship? In other words, would a significant upgrade lead certain funds to commit to a stock? Or do funds have their own internal resources to gauge strength of an equity?

     

    Thanks.
    22 Apr 2013, 12:02 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (111) | Send Message
     
    I understand what you are saying. Perhaps I wrongly thought that with an approved drug, an ever expanding patent portfolio, a large target market etc, that the in and out trading would mitigate and there would be some pps stability. I haven't followed any drug launches before and therefore don't know if there are any tell tales signs to consider on this one. The increase in monthly script totals from Feb to March were an impressive 128%. Clearly that percentage increase month to month wouldn't be sustainable through the next 9 months (IMO), however if we even sustain an average 50 % growth rate month to month for the next 9 months, that would be very impressive. Any opinions on launch trends that you have been involved with or know about?
    22 Apr 2013, 12:15 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » depends, I don't go strictly on those recommendations though, just a foundation for info and looking at other peoples thesis.
    22 Apr 2013, 12:30 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » My opinion is the launch is tracking as expected/well, given their size sales force and only being a couple months in. Many in industry would not even look at the data until several more months have passed to get good pressure check on trend.
    22 Apr 2013, 12:32 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » I stand corrected, a fellow SA associate told me that AF did mention patents and script trend in latest article (albeit in a negative light)...I just did not read past page one of this article since it's such garbage...tells you how much weight I give to AF statements/articles, not even worth my time to finish the content
    22 Apr 2013, 12:34 PM Reply Like
  • coopman98
    , contributor
    Comments (69) | Send Message
     
    must be good news between AF and Raven coming put with negative (short ) articles. what a joke
    22 Apr 2013, 03:10 PM Reply Like
  • framus_morrigan
    , contributor
    Comments (76) | Send Message
     
    coopman98, the joke is :

     

    "Amarin Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High Triglycerides (>200 mg/dL and < 500 mg/dL) with mixed dyslipidemia"

     

    Congratulations for all longs !
    :)
    23 Apr 2013, 06:40 AM Reply Like
  • Pirateescapee
    , contributor
    Comments (111) | Send Message
     
    Wow! 2 scathing unfounded hit pieces out of the blue yesterday and sNDA acceptance today. The timing is very suspect, indeed! Didn't one of the authors claim once that he had connections inside the FDA?

     

    I hope one day the SEC sees fit to shine a light on that person. Intentional and malicious manipulation.
    23 Apr 2013, 08:52 AM Reply Like
  • golfstud
    , contributor
    Comments (52) | Send Message
     
    Yes great news and comes 58 days from submission. Steve what date approximately do you expect we hear of approval for anchor? Thanks
    23 Apr 2013, 09:37 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » FDA date is Dec. 2, and kind of regardless since strategic partners/suitors would get involved prior, approval is a given.
    23 Apr 2013, 09:38 AM Reply Like
  • User 7643291
    , contributor
    Comment (1) | Send Message
     
    Steve,

     

    Does Amarin produce V enzymatically and then purify? Or is it just purification of the isomer from crude extract?

     

    How much of supply does Amrn control, and how much will they control with agreements currently under discussion?

     

    Thanks
    22 Apr 2013, 11:25 PM Reply Like
  • gtgtbangbang
    , contributor
    Comments (100) | Send Message
     
    from what I have read, it seems refining is distillation to a point, then "chromatographic", or transport rate, using special reactors, for separation.

     

    Steve - I am curious how the high/very high EPA% OTC drugs are manufactured. Have not seen details on those ( although the lack of detail on these touted OTC alternatives runs the gamut from box to capsule contents )
    23 Apr 2013, 09:34 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » You can attend an upcoming science and raw material conference on this topic with me in May if you like :-)
    23 Apr 2013, 09:39 AM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » AMRN currently controls just about all material commercially available through supply agreements and patents in this range, that is why it is seeking additional suppliers and filing more sNDAs for them.

     

    Purification process is multi stage from what I understand, not enzymatic - and is proprietary, hence the trade secrets in addition to patents (meaning nobody knows the exact process except AMRN)
    23 Apr 2013, 08:44 AM Reply Like
  • golfstud
    , contributor
    Comments (52) | Send Message
     
    Steve,

     

    Am i missng something as a pretty big announcement today about anchor and the price per share is basically flat. What gives?
    23 Apr 2013, 12:14 PM Reply Like
  • Pirateescapee
    , contributor
    Comments (111) | Send Message
     
    Todays sNDA acceptance announcement actually emboldened the short players as it was met with little to no real buying and just some transient covering and reshorting. It is one more supposed "catalyst" out of the way for them. There is zero institutional buying here which leads to the question "why"? I can only speculate that the exclusivity overhang which apparently halted any commercial collaboration has resulted in a focus on script growth and a wait and see approach. Until that dynamic changes, it appears we go nowhere.
    23 Apr 2013, 12:51 PM Reply Like
  • Not_Quite_Pheidippides
    , contributor
    Comments (409) | Send Message
     
    Pirate -- well, as you said, "Until that dynamic changes, it appears we go nowhere"... here's the problem that I see: the longs who are in based on trials / results, are already in. There are no revenues or earnings or multiples to date, so no number crunchers to be involved, either. In the meanwhile... it is a short's playday.
    26 Apr 2013, 01:22 AM Reply Like
  • Iamstockgeniusjustaskme
    , contributor
    Comments (248) | Send Message
     
    NQP,
    It is shorts field day until Nce yes hopefully or Anchor approval. Time wil tell, my intuition told me to sell as soon as they announced GIA. I didn't and regret as I think if we sold at Gia get back in at 7.00 or so we be alright, hindsight is always 20/20 isn't it?
    1 May 2013, 03:47 AM Reply Like
  • framus_morrigan
    , contributor
    Comments (76) | Send Message
     
    Hedge Funds and shorts are in control right now.
    This is how market works.
    :(
    23 Apr 2013, 05:39 PM Reply Like
  • Steve Rosenman
    , contributor
    Comments (765) | Send Message
     
    Author’s reply » i believe you are right, only way to explain it. stay away until some reason starts kickin in.
    23 Apr 2013, 08:08 PM Reply Like
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