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In Fact IMO FDA deliberately obscured the data showing cv reduction in those trials in the 200-500 group. They just sat there when the question came up and they full well knew the answer
Actually there is evidence even in the trials they cited. They just chose to leave it out of the discussion.You can't tell me that they are that stupid to not have known the in the 200-500 group even in the 3 trials they cited cv events were reduced. Go look at post 1062 at investor village you will see it for yourself. Results that were not presented at adcom
I see your point with the exception of the media attention a huge law suit could bring. The politicians would line up for a chance to be seen looking into it
No the slides on the inv.vl. post 1062 were not used and only a brief fumbled reply when the subgroups were asked about.
WERE Subgroups of 3 failed trials even mentioned at the Adcom? I can't find that it was. If not how does a room full of so called experts miss that?
LINK to new web site please?
FDA stated in its October 29, 2013 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL). Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.”
Those 3 trials enrolled very few patients with Trig levels between 200 and 499 mg/dl.
However, those patients that they did enroll in that range consistently suggested better outcomes when compared to those with lower baseline Trig levels. This suggestion of benefit was observed in ALL 3 trials.
from post 1062 investor village board. Shows the report findings specific to the 200-500 group
Reply from Peter Whoriskey!!!!!!!!!!!!!! By koleminer1 • 19 minutes ago yaho board
Yes I did read and it is definitely of interest. I am swamped now, however, with a couple of stories that have to be done immediately.
I will talk to the editors today, if I can. Maybe we can talk next week?
Sad to say many of the freedoms we now enjoy have been a result of litigation being taken all the way to the supreme court. Usually because some lesser government entity that wants to violate legal rights guaranteed by the constitution. It looks like right now the FDA wishes to follow that path.
LOSING FOCUS upset as we all are at the FDA IMO a diversion away from the real war. That is selling Vascepa scripts. You see back in the 1990's a similar war was fought to get trans fats banned from the US food supply. They were banned in European countries but in the USA the FDA and their corporate buddies resisted and FDA would only mandate they be listed on the food label. The consumer then abruptly stopped buying anything with trans fat.For example the result was Hostess products sales declined rapidly to bankruptcy. You cannot hardly find any food being sold with it on the label in the USA. Amarin needs to play up the more natural way Vascepa accomplishes triglyceride and inflamitory reduction verses the chemical compounds now being used. IMO the same thing will happen even with off label sales. The drastic reduction of side effects by the use of Vascepa is very real as many of it's users have commented on these boards. If that is done IMO the consumer will do the rest and very rapidly so.
Absolutely right , That being said is not an adcom a sort of informal glorified meta analysis discussion intent of which is to consider all the science regarding a treatment? How is it that the FDA can say all discontinued for safety trials fit the definition of approvable trials and fit for discussion, any more than a meta analysis? Also to ignore the majority of all previous studies those meta analysis quote? I guess it's best to ignore the reality of other scientists. I guess they think the best science is to keep your head in the sand.
Which EVIDENCE? "Evidence
Based Medicine" None of the new meta analysis evidence regarding EPA was even mentioned by the FDA and continues to not receive any mention or consideration, only the bogus failed trials. The only way it will ever be is in a court of law or maybe by some official outside of the FDA. It's clear to me there is more than following a mandate going on here. I doubt I will ever invest in a bio again. The only disclosure of what's really going on is when leaked info shows in the trading and by then it's too late. I think Amarin's only hope is in the legal system as it's clear they have been cheated. Maybe the threat of that will carry some weight in allowing something positive to come out of this.
IMO big pharma has heard how Vascepa has been well revived by many of their statin users and how they have been able to cut back on those and other drugs. They are trying to keep a lid on Vascepa as long as they can.
HERE IT IS speedrunner199 • Oct 25, 2013 7:36 PM Flag
11users liked this postsusers disliked this posts0Reply
Discussion with AMRN Investor Relation-Part 1
I recently had a long discussion with AMRN investor relations (Joe Bruno) and would like to share the info discussed with the MB.
1. re FDA panel meeting: FDA never informed AMRN regarding the requirement of outcome study for Anchor approval or their intention to break the SPA prior to the panel meeting. They were completely surprised with the FDA’s linking outcome to vascepa lowering of TG. They have not given up on Anchor approval and will do everything possible to challenge the FDA requirement of outcome for Anchor approval- all options will be expended. These points were reiterated several times. My impression was that they also did not have any discussion with FDA since the negative panel vote but all options are being considered.
2. re Reduce-It trial: For now, Reduce-It study will continue and have been budgeted into 2014 revenue projections. The projected $80 million burn rate for 2014 includes the expense for Reduce-It study. However, decision on this could change after additional meetings with FDA. (I reiterated my position that completion of Reduce-It is crucial to future potential for AMRN and it would be a huge mistake to abandon Reduce-It).
3. re Finances: I raised a concern regarding decline in revenue with reduced sales forces. He felt quite strongly that based on their analysis and data on highest prescribing doctors and top revenue generating sales people that the sales growth will continue at a steady rate and that reduction in force will not have a major impact. He also felt that the continued sales increase will be able to support expenses and that no additional funding will be needed and that no dilution will occur. I asked about stock sales possibly in 2015 or 2016 but he was adamant that based on their projections they will not need to raise additional funds to complete the Reduce-It study. (I found this position to be very interesting and perhaps the cost cutting and increase in revenue may balance by sometime in 2015. cont--- Less
Sorry should have copied the Yahoo posts. Looks like they got pulled.I took a few minutes and looked for the investor village posts re the Type A meetings.I found some in post 986 and above. The gist of it is if the spa in a material way had changed in the view of either party a type A meeting has to occur. That also would require Amarin to file a form 8 reporting the change. So if no report is filed before the pdufa date regarding a material and substantial change in the SPA, then the "science" is not or has not changed in the eyes of either party to the spa
As Far as a law suit by Amarin against the FDA. If they do renege the spa. I would be suing for all the lost company and shareholder value and the 10 billion a year the indication would be worth. So say it takes them 3 more years to finally approve, and we all know Vascepa will show a benefit, 30 to 40 billion? Think that would make the national news? Then this whole stink would be out in the open. The FDA would surely be on the hot seat. I wonder if those who leaked info before the adcom would want that? IMO the reason for no nice is to avoid the legal war that would ensue. Why would the FDA want to pick this time to open a much bigger can of worms if they passed on the NCE debacle? Just ramblings from a frustrated shareholder
for what it's worth it was posted on the yahoo board. AMRN investor relations replied that they had NOT had any discussions with the FDA since the adcom.
It was also posted on the Investor village board that Amarin has to request a discussion and by FDA guidelines would have to wait 4 weeks for a discussion date.
Either these posts are accurate or Redacre is, both can't be
FDA reneged spa just google that go to ivestorvillage or use the link. The tread has all the details on the protocol in this instance http://www.investorvillage.com/mbthread.asp? mb=2294&tid=13220049&showall=1 IN other words this science issue, if thats what it is, is far from over
Young Capital Management, LLC is a Registered Investment Advisor with the state of California and is based in Los Angeles. Joshua Young is the managing member of Young Capital Management. He was recently featured in an article in Oil & Gas Investor Magazine and in The Energy Report. http://www.youngcm.com/
Young's comment in Seeking Alpha:
Dejour is intriguing, and has lots of upside from a lot of different perspectives (rising nat gas, ngls, cash flow, reserves, etc). But I think Gale Force and Austex may be even more interesting. I own all three, but my Gale Force and Austex positions are bigger.
DEJ Institutional Holdings
By harold33272.Oct 12, 2012 4:46 AM.Permalink
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Young Capital Management is a new institutional holder of Dejour. It's also the largest stakeholder in Lucas Energy, fyi.
Sentiment: Strong Buy
from the yahoo board
WILL Nat Gas price tank again ?..NO Do you think supplyers will allow another glut again. NOPE they are planing on exporting etc. From now on they will be much more careful about supply vs demand, just like opec.IMO it's easy logic So in other words DEJ has substanilly been de-risked
AUSTEX AT .16 HIGH OF DAY ON AUSTRALIAN EXCHANGE
http://www.austexoil.com/IRM/Company/ShowPage.aspx/PDFs/1409-10552303/MissLimeHorizontalWellresultsexceedexpectations
Nat gas breaking out UP 4.3% made a high of 4.5%
CNBC Reports morgan stanley says $5 comming by 1st qtr.
http://video.cnbc.com/gallery/?video=3000121803&play=1
Ya it is, we need all the funnies we can get in this market. Thanks for the pun lightens up the day a bit
Here's the link ............http://www.cnbc.com/id/49323279
David Lennox sees Good Potential in Natural Gas: Analyst
David Lennox, resources analyst at Fat Prophets, sees significant potential in natural gas and thinks there is opportunity to buy into U.S. natural gas fields.On CNBC today video story title "Oil Eases on China Growth Warning" sees significant potential in natural gas
WOW Volum at 10 million shares up 19% on the Austrailian exchange
Buy
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Last
MktPrice
Change
PctChange
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TotalTrades
0.16
0.16
0.14
0.16
0.13
0.16
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10,592,594
254
AOK delivers 75% increase in production for June
United States focused oil & gas produer AusTex Oil Limited (ASX:AOK – OTCQX:ATXDY) is pleased to report oil and gas production rates for the month of June 2012.
Production for the month of June increased to 299 BOE, a 75% increase on the prior month. The increase was due largely to the contribution from the Balder #1 horizontal well, in which AusTex participated with Range Resources Inc. (NYSE: RRC). Improved production from the Company’s producing vertical wells also contributed. http://www.austexoil.com/IRM/Company/ShowPage.aspx/PDFs/1390-23098175/Austexreports75increaseinProductioninJune
http://www.austexoil.com/IRM/Company/ShowPage.aspx/PDFs/1391-85956018/QuarterlyActivitiesandCashFlowReportforJune2012
They have completed clinical/lab tests, now in drug production in readyness to enter phase 1 trials. To do that they have to file an IND with the FDA and have that accepted.WE are waiting now to hear that news.
Delistments Means Little to Nothing
The End Of An Era; The OTCBB Has Been Replaced By The OTCQB
http://www.reverse-merger.com/the-end-of-an-era-the-otcbb-has-been-replaced-by-the-otcqb/
Please Let the price drop I want some more before the new news
As a cancer survivor/investor I am buiding a position here. I resisted to sell my .30's. I got an order today filled AT.52. I like the tech with this one.Looking at the 2yr chart I could have waited for lower pps. as some think will be the case. I think this is rebounding from the IPO dip especially with the lab results. Bio's are always all over the place. Today the euro killed much of the pps. It was nice to have some dry powder to pick up a few before the next leg up.
Did you notice the major oil companies that are clients of the firm? Like has been said before, these guys are probably doing a favor for an old friend and his son by being involved with SIOR. They definitely don't need the money.
A SCAMMER??? I DON'T THINK SO!. Jhttp://www.chambersandpartners.com/UK/Editorial/43273
"James George is a greatly respected member of the Oklahoma legal community. He is described as "the elder statesman" of the Oklahoma Corporation Commission (OCC), the state's oil and gas regulator, due to his many years of experience representing clients before the commission" Listed as a director of SIOR
http://crowedunlevy2009.publishpath.com/Websites/crowedunlevy2009/Images/Atty%20Bios/George.pdf
OEDV PPS IS WHAT ? YA THATS WHAT I THOUGHT 1.50 OR SO!!!!
USUALLY IN THIS MARKET PPS OF OIL CO ONLY GOES UP on production results . Here we have seen .03 recently. SIOR is IMO rather well known and has been around quite a while. Any drilling news I expect something like a double in a minute or less.I got most of my shares at .006. If you want you can wait for production and thus reduce your risk but your cost pps will greatly reduce your gains.Example look at DEJ 2 or 3 times the leases as SIOR and it sits at .24 some production and now set up to begin the next phase of drilling. It should be at $1 based on estimated reserves. But mostly in unproven plays. Even with that it has spiked on each news as high as .80. SIOR'S leases are all in a proven play and has wells with some production that with the new horizontals could be reworked to become very profitable.
OP SHARES CAN BE VERIFIED BY THE STOCK TRANSFER AGENT RECORDS seems to me this subject was addressed quite some time ago on this board in depth. If anyone really is wondering if Sior is dilluting all they have to do is check with the stock tranfer agent of SIOR. In the morg files of my little brain I seem to remember it was verified that the OS was in fact still 200 mil.. IMO anyone who thinks .02 ps or anything near it, will last more than 60 seconds after drilling is announced is certifiably nuts.
NICE NEWS CLIP THANKS GO SIOR!
Don't think it's the same company