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  • Amarin: Slow And Steady Wins The Race [View article]
    BiotechWill,

    I think the 2Q CC will be the tell. I have heard much chatter that the company raise in early July was to create greater flexablility, add muscle to the B/S etc etc. Basiclly, even though they diluted at 52 week lows, it was done to get ahead of the curve of issues big shareholders and WS had regarding cash. The move was made from a position of strength, if that makes any sense considering it was done near multi-year lows. LOL. Nevertheless, I think the 2Q CC comes down to one major issue. Cash burn. As long as the cash burn is LOWER, and there are no surprises, then I believe we will be in fine shape for a good call to help turn this ship. However, if there is a cash burn negative surprise, then I believe the evidence would be crystal clear that large shareholders were misled...again. More importantly, tis would prove beyond doubt that the company still is clueless of the mechanics of WS. What a negatative cash burn surprise would mean is that the company diluted from a position of weakness, only days after they shut their books for Q2. It would also mean that the company misled many, since the spin machine has been in full force privately that the raise was for positive reasons....
    Aug 6 04:15 PM | Likes Like |Link to Comment
  • Amarin Strategic Moves [View instapost]
    Steve,

    What is everyone talking about regarding the JPM notes and rumors? I have the full JPM AMRN 7/23/2013 notes from the company and it tips to nothing on the sort. Not sure if you have the notes, but I would be more than happy to email them to you. Am I missing something or are you looking at something else?

    Thx
    Jul 25 01:29 PM | 1 Like Like |Link to Comment
  • Amarin's AdCom: Two Fish With One Hook [View instapost]
    I believe it is relevant to the discussion. There are many ways that the FDA can 'break' the SPA. I am not suggesting they will, and I believe they won't, but they still COULD. Yes it would be material, and yes, it would have to be disclosed, and it could still happen at any time leading up to the ADCOM. I think if you included the "lengthy" facts behind SPA's as per the FDA, it would allow the readers to re-vist all the facts regarding SPA's. I don't believe how safe Vascepa is has ever been in question in regards to Anchor approval. Even bears would agree on that. I think it's in the weeds of that "lengthy" additional reason's the FDA could decide to "break" the SPA that have some nervous. It's a grey area, and it proves that the FDA COULD alter the SPA for pretty much any reason they want. That is where the risk is IMO.
    Jul 1 04:54 PM | 1 Like Like |Link to Comment
  • Amarin's AdCom: Two Fish With One Hook [View instapost]
    You should have included ALL this in your SPA discussion...

    Special Protocol Assessment
    http://1.usa.gov/135JvYc

    B. Changes in Documented Special Protocol Assessments

    As stated in the PDUFA goals for special protocol assessment and agreement, having agreed to the design, execution, and analyses proposed in protocols reviewed under this process [i.e., carcinogenicity protocols, stability protocols, and phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim], the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.

    Thus, documented special protocol assessments should be considered binding on the review division and should not be changed at any time, except as follows:

    Failure of a sponsor to follow a protocol that was agreed upon with the Agency will be interpreted as the sponsor's understanding that the protocol assessment is no longer binding on the review division.

    If the relevant data, assumptions, or information provided by the sponsor in a request for special protocol assessment change are found to be false statements or misstatements or are found to omit relevant facts, the review division will not be bound by any assessment that relied on such data, assumptions, or information.

    A documented special protocol assessment can be modified if (1) FDA and the sponsor agree in writing to modify the protocol (section 505(b)(4)(C) of the Act) and (2) such modification is intended to improve the study. A special protocol 9 assessment modified in this manner will be considered binding on the review division, except under the circumstances described below.

    A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun (section 505(b)(4)(C) of the Act). If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management.
    Jul 1 02:49 PM | Likes Like |Link to Comment
  • Ahead Of The Curve: Amarin To Release Better Than Expected Combo/Statin Data [View instapost]
    Steve,

    Question....what on earth is AMRN thinking?? They have been sitting on combo data for MONTHS. It was data that they had complete control to the how, and when they could release. So what do they do? They release a weak pr with no hard data, on a Friday, in the summer, hovering at fresh 52 week lows, hours after the market had it's worst day this year. I mean, are you kidding me??
    Jun 23 09:12 PM | Likes Like |Link to Comment
  • Ahead Of The Curve: Amarin To Release Better Than Expected Combo/Statin Data [View instapost]
    Steve,

    Were these the better than expected results you were expecting?
    Jun 22 12:26 PM | Likes Like |Link to Comment
  • Ahead Of The Curve: Amarin To Release Better Than Expected Combo/Statin Data [View instapost]
    Steve,
    Do you think that going from "good" combo/stain data to "great" combo statin data alone will be enough to actually move the current pps higher in this enviroment for the company? Every catalyst since late last year has been met with pressure and more pressure. Aside from being attached with a partnership or another type of deal, what will make this "cataylst" different from the others? Thx
    Jun 17 04:05 PM | Likes Like |Link to Comment
  • Scripts [View instapost]
    Since launch, the shorts, bashers, etc have successfully run over every single catalyst that the company has; every single milestone they have achieved. Patents, sNDA file, sNDA acceptance, additional suppliers, etc etc etc. Every catalyst. Now lets assume that the big combo news, that we have all been waiting for (including shorts) is not just good, but great. Now if it is tied to a BP deal in some way then that might be the rocket fuel we need to get things going. But lets just assume its just "great" data. Do you honestly think that "catalyst" will be treated any differently from the other "catalysts" that we have apparently had over the last 6 months? I am convinced that JZ and AMRN must do some lifting on there own regarding pps if they are going to get a acceptable BP offer. ($25-32) A BP WILL NOT pay a 300-400% premium. Not going to happen, even if the acquired company had the cure for cancer, hunger, and world peace. AMRN is going to have to find away to get the pps up on their own ($11-14 should do it) first. Then they will be in a better position with a healthier stock. BP has shareholders to answer to as well. Otherwise I would think that a partnership of some sorts would be their path. To be honest? I thought maybe that "something" was more concrete by now, linked to combo results. It sounds to me by some of the investigating you have been doing, that we are still not where we want to be yet. Your thoughts are appreciated....
    Jun 15 10:38 AM | 1 Like Like |Link to Comment
  • Where Is Amarin Really? [View instapost]
    Good overview, all great points. You reference the previous milestones with the stock with NO approved drug, patents, etc etc at the time and compare to where we are now having achieved all these incredible milestones. The disconnect seems to feel that at the time in 2010 and 2011 per your reference the belief was that AMRN would never sell Vascepa on their own, that a buyout would take place prior to any launch. Like you, I have been involved with AMRN early. The buyout dance has been going on for many years. Now here we are, launching on our own, and having to deal with all of the challenges that come with a solo launch. Is NCE clarification the hold up? Is it something else? How do you feel about JZ's comments on the most recent cc regarding 3rd party for Anchor? I feel he has again played into his weakness on delivering his message to investors. Why tell WS over and over you are for sale, or looking for partner? Why not sell the street that AMRN is full blown GIA, preparing to make billions, and show that confidence? It just seems that while he has been on point with business milestones, he still is off when it comes to investor relations.
    May 15 03:59 PM | 2 Likes Like |Link to Comment
  • Price Target Update For Amarin (AMRN) [View instapost]
    So from what you are saying, I would assume that could mean a partnership of sorts? That would surprise me. JZ had always mentioned partnership as one of the 3 commercial path's, but at the same time he would always comment on the negatives of them. Kinda like the "bronze" of the three choice's.
    May 8 03:47 PM | 1 Like Like |Link to Comment
  • Amarin Vascepa Sales Data Misleading [View instapost]
    Steve,

    Wasn't that part of the promotion you are referring to (1000 docs given 5 free bottles each) given pre launch, or at launch, which now is roughly 7 weeks ago? I would have expected that we would have already seen some of those trickle into as paid scripts by now.
    Mar 26 06:42 AM | Likes Like |Link to Comment
  • The Price May Be Increasing For An Amarin Buyout [View article]
    Steve,

    Any particular reason you have gone dark out of all weeks, this week?? You never posted that picture your contact at JPM conference said he took as well. Not that it would make a material impact on anything, but from a credibility standpoint, or lack of in refering to AF, there would be some significance among those who follow you and the company closely.

    Thanks....
    Jan 17 05:43 AM | 1 Like Like |Link to Comment
  • The Price May Be Increasing For An Amarin Buyout [View article]
    You are incorrect. NCE does not start until decision is made by FDA regarding exclusivity. In a way, the delay has helped AMRN, for it has already given them close to 6 bonus months of exclusivity, regardless if FDA chooses NME or NCE
    Jan 4 04:01 AM | 1 Like Like |Link to Comment
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