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That statement alone deserves some buying in the pre-market.
From p.10 of the new slide deck, TG as predictor to CHD is at least as good as LDL-C, unlike HDL-C. From p.12 of the new slide deck, seems like a >=20% efficacy @ interim readout is sufficient to halt the R-IT trial.
I respect Kiwi a lot and wish him long and healthy life. He is the Sy Sperling of this message board, President of the Satin Club:
Rosey, Zetia 2013 sales is over $2B. Wasted dollar for something that could be harmful, thanks for FDA and BP's marketing prowess.
James, thanks for the info. All blood lipid panels include trig. measurement. Interestingly, your provided slides don't include % CAD patients Vs. trig. level. That's a disappointment and waste of R&D dollar for them to miss trig. even though it's such a common lipid panel parameters. Seems like those scientists and researchers are very narrow-minded and not curious enough to find out the true cause of CVD.
I think that restriction applies only to Amarin as far as FDA is concerned, LOL!
Jason Napodano tends to push for penny stock. My guess is he is going to recommend Matinas BioPharma (stock symbol MTNB) tomorrow morning for his stock service. See the following links for info. on MTNB,
http://finance.yahoo.com/news/matinas-biopharma-completes-enrollment-first-120500247.html
and http://www.matinasbiopharma.com/pipeline/mat9001-development-program
Thanks HD. I know I can count on you.
HD, IMPROVE-IT 6% MACE reduction was deemed successful while R-IT requires at least 15% MACE reduction for success. Do you know why there is such a double standard?
HD, thanks. Do you only sleep 3 hrs a day? 2:00 am to 5:00 am? I am just being nosy and you don't have to answer this. I am heading to bed now and thanks for all your informed views.
BC, I hope there is no more partnership deal. Why give away the store unless you have to? Plus the China deal is totally out of the left field. Nobody mentioned or thought about China deal before it was announced. It's like new found money underneath the sofa cushion.
HD, thank you so much. So as long as any one of those 16 patents hold up, those generic companies would infringe. Seems like Amarin gets to pick which patents to defend which makes the defense even stronger.
HD, I am glad you agree with me.
Regarding generic companies' Vascepa patent challenges, do they challenge all the patents at once or just pick a few weak one to challenge? Vascepa has over 40 patents, I would think at least a handful of them are very strong. Especially, the invention of lowering trig. without raising LDL is novel, non-obvious and unexpected.
Rosey, that's the distinct impression I got when I followed Joe Z's conference calls during late 2012 and early 2013 Then AZN's acquisition of Omthera shortly after further cement my suspicion.
Do you remembrer Joe Z saying, "NCE is a gold medal, no NCE is a silver medal and no decision is a bronze medal". He would rather no NCE than no decision at that time, which turn out to be true.
BC, agree with you on his presentation skill, but I am very impressed with his execution of the business plan except I wish he could make more progress in insurance coverage.
Without the FDA screwing around with Amarin, we will never be able to buy the stock at $1 & $2 range. IMO, the company would have been bought by AZN had Vascepa got the NCE designation upon its approval in 2012.
Jun 2 2015 presentation @ Jefferies 2015 Global Healthcare Conference should be in a more upbeat tone.
http://investor.amarincorp.com/events.cfm
"If it fails, we're toast." I can't disagree more. I wrote the following on 5/24/2015:
Zetia annual sales is over $2B. That's for a drug that reduces annual MACE event by 6% in combination with statins. RI will be a home run, IMO, but don't have to be. Even a 15% MACE reduction will translate into a billion dollar drug. So what if we have to wait extra 2 years for final RI readout if no interim stop. Amarin has 2 years worth of cash runway, growing sales, improved margin and rich backer such as the Baker Brothers. China money will start to roll in 2018/2019. They also have other strategic levers to pull if they need to. The day of worrying about Amarin survival is over.
Right now the market has priced in the worst case, i.e., Vascepa not a NCE, no ANCHOR approval, RI readout till 2018, etc. What happen if we get a +ve ruling from Judge Moss, a win in the 1st amendment suit, +ve 2016 RI interim result. I would think the upside is many times greater than the downside. That's what I call asymmetrical returns, something i try to look for everyday in the stock market.
***
The company will survive with even 10-15% MACE reduction for Vascepa.
Tell that to Ajax about $1 salary for the management.
Thank you Mr. Market for a great buying opportunity today.
No need to be disappointed. I treat it as a buying opportunity.
"The credit for the NCE reversal goes principally to Amarin's management". I am sure Ajax would agree with you.
On 9/5/2014, Depomed Summary Judgment Motion Granted in Suit against FDA Seeking Orphan Drug Exclusivity for Gralise® (Gabapentin)
http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&ID=1964344
On 11/3/2014, FDA Appeals Depomed Orphan Drug Case
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/11/fda-appeals-depomed-orphan-drug-case.html
On 11/6/2014, FDA Withdraws Appeal in the Depomed Case
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/11/fda-withdraws-its-appeal-in-the-depomed-case.html
On 12/23/2014, FDA Issues Post-Depomed Policy Statement
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/12/fda-issues-post-depomed-policy-statement-agency-doubles-down-on-clinical-superiority-requirement.html
I assume FDA will use similar tactic for the Amarin case.
Thanks JL for your accurate read on the NCE court transcript. Go Larry Fucsten indeed!
NCE exclusivity really means 8-yr exclusivity until generic competition at the earliest. So it's a big F'ing deal, third importance only after Vascepa patents strength and REDUCE-IT success. The market value gained with Vascepa NCE status is tremendous and can be quantified.
*****
NCE exclusivity is explained in the FDC Act vis-à-vis the submission and approval of an ANDA (at FDC Act § 505(j)(5)(F)(ii)) or a 505(b)(2) application (at FDC Act § 505(c)(3)(E)(ii)) for a drug product containing an active moiety protected by NCE exclusivity. For example, FDC Act § 505(j)(5)(F)(ii) states:
If an application submitted under [FDC Act § 505(b)] for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under [FDC Act § 505(b)], is approved after September 24, 1984, no [ANDA] may be submitted under [FDC Act § 505(j)] which refers to the drug for which the [FDC Act § 505(b)] application was submitted before the expiration of five years from the date of the approval of the application under [FDC Act § 505(b)], except that [an ANDA] may be submitted under [FDC Act § 505(j)] after the expiration of four years from the date of the approval of the [FDC Act § 505(b)] application if it contains a [Paragraph IV certification]. The approval of such [ANDA] shall be made effective in accordance with [FDC Act § 505(j)(5)(B)] except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the [NCE NDA], the thirty-month period referred to in [FDC Act § 505(j)(5)(B)(iii)] shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the [NCE NDA].
****
You also get additional 6 months of pediatric exclusivity.
AP, I think you can relax and take your time to accumulate. One thing Amarin is not short of is buying opportunities. No generic competition until July 25th, 2020 is a big deal, especially if successful R-IT interim readout in 2016.
AP, I remember you didn't think Amarin could win the NCE case based on your reading of both sides' testimony. I am glad you are wrong. The market will always undervalue any Amarin victories, hence presenting buying opportunities for patient long-term investors.
Remember "Right" is on our side. 1st amendment lawsuit victory next followed by successful R-IT interim readout.
Thank you HD and JL to be the guiding light of this board.
No generic Vascepa until July 25th, 2020 at the earliest. Great news.
Raf, thanks for the great news. +ve NCE is the third most important issue on my list, second only to patents and R-IT success.
My best guess is Judge Moss NCE decision. It could also be due to Kiwi giving up Crestor for 6g/day Vascepa.
2015 R-IT interim readout?
A leak from the Honorable Judge Moss? A leaked script number for tomorrow? What's going on?
Nuke, make sure you cancel it as soon as possible. Otherwise, they'll bill you $39.95/month till eternity. That's how they make their money and it's a total scam. If I were you, I won't ingest any unknown substance unless I know its true content.
Invest, if you don't need cash now, will you sell your vacation home? I am pretty sure EU right for Vascepa is more valuable as time past.
"If these same JELIS patients had got their LDL under 100 with stronger Statins like Crestor ....would the results have been even better ?"
In Jupiter trial, the test subjects has normal LDL level, not at 178 LDL. So I truly don't know the benefit of taking Crestor at high LDL level. Do you know of any double blind placebo control study for Crestor with test subjects that have abnormally high LDL? That might change my mind.
Kiwi, you are our resident statin expert and proponent. I didn't realize my simple question is so difficult for you to answer.
Kiwi, who you rather be? Jelis patient at 178 LDL or R-IT patient at less than 100 LDL, and why? TIA.
2.22 times the dosage to be exact.
Toothpaste is not covered by insurance and nobody is willing to spend much on a tube of tooth paste.