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I don't know about eyes on the message boards but investors were allowed to ask questions and they tried to incorporate answers into their prepared remarks.
"To Ask Questions:
During the teleconference, following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations. Participants in the live teleconference will be provided an opportunity to ask questions. Investors may also e-mail their questions to investor.relations@amarincorp.com. E-mail questions will be accepted until 4:00 p.m. ET on Tuesday, May 1, 2018 "
They (ESPR) can't be pleased with these results. I believe there is another trial before they file but you have to wonder if FDA will require CVOT before approval.
AMRN had already guided that they were having slow sales at the beginning of the quarter. That is one of the reasons why some have been dumping shares. Based on earnings announcements and discussions so far this year it turns out many big pharma and biotech saw the same issue this first quarter.
I heard adjudicated or scheduled.
APD-371 is in a phase 2 trial. The phase 1 trials are complete.
They may both have the word VITAL in the title but they are not the same study
For those who still had doubt, It is good they cleared up timing of Reduce-it in press release.
"The results of this important study are anticipated before the end of Q3 2018."
Wow, 'by the end of the third quarter' means by the end of the third quarter. It could happen any time before the end of the third quarter.
Americans live with a lot of obesity and obesity is bad for your heart.
CTO appears specifically related to distribution agreements. I have not read through everything on this board from the last 24 hours so this may have been pointed out.
Amarin back on February 27th asked for confidential treatment of these two exhibits. One is the Canada distribution agreement and the other is the Middle East distribution agreement. I do not see how the timing of the SEC responding to Amarin's request for these arrangements is related to what is going on in the courts or at the FDA. These request to keep terms of agreements be kept confidential are pretty standard. The two actual exhibits, with the confidential terms omitted can be seen on the SEC website.
"Amarin Corporation plc submitted an application under Rule 24b-2 requesting confidential treatment for information it excluded from the Exhibits to a Form 10-K filed on February 27, 2018.
Based on representations by Amarin Corporation plc that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it. Accordingly, excluded information from the following exhibit(s) will not be released to the public for the time period(s) specified:
Exhibit 10.67 through December 31, 2022
Exhibit 10.68 through December 31, 2022
For the Commission, by the Division of Corporation Finance, pursuant to delegated authority:
Brent J. Fields Secretary"
Amarin, using their twitter account.
AMRN @Amarincorp 3h3 hours ago
Tomorrow is National Triglycerides Day! Talk to your doctor about your triglyceride levels. #TGDay2018
I have a hard time believing it as well. Normally a site would have a limit, a maximum number of patients they can enroll. Do not enroll more than 60 patients, as an example. If there are other sites who do not end up enrolling enough, sponsors would allow additional enrollment to no more than 80 patients as an an example. As much money and effort that AMRN has put into this, I do not believe they would have concentrated that large of a percentage of patients in a smaller country.
APD371, an agonist of the cannabinoid receptor 2, is actually in a small Phase 2, 8-week trial for visceral pain associated with Ulcerative Colitis. The company was very pleased with how well the single and multiple dose phase 1 trials went. The company was able to test higher doses of the drug than they thought possible without side effect issues.
STS66, Before I saw your post, I was thinking that AMRN was suffering from the same type of take down that ARNA suffered from. They were both over the period of monthly options expirations. It is true AMRN is not as close to a binary event but they are both binary events this year and the take downs looks very similar.
BB, Thank you for staying on this. If nothing is posted today, how do you think the court will proceed forward?
AMRN Short Interest Update
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
2/28/2018 7,830,992 1,415,727 5.531428
2/15/2018 6,377,570 2,186,535 2.916747
1/31/2018 7,595,054 3,696,288 2.054779
1/12/2018 7,408,928 1,262,483 5.868537
12/29/2017 6,989,767 2,162,404 3.232406
12/15/2017 7,140,125 1,753,777 4.071284
If you do not take a magnesium supplement you might want to try a low dose of that, 100 - 250 mg a day, to keep your heart rate lower.
I am trying to figure out what this would look like under your scenario. This is from Caremark.
Vascepa
Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet and exercise regimen before receiving Vascepa and should continue this diet and exercise regimen with Vascepa.
Attempts should be made to control any medical problems such as diabetes mellitus, hypothyroidism, and alcohol intake that may contribute to lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use
The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
If TG will be irrelevant post R-I than what indication will be used to get insurance coverage? What indication will AMRN file for to the FDA?
Vascepa indication is currently only for TG > 500. I think the ACC has lowered guidance on when to treat but it It would not matter at this point what the guidelines are until we get the indication changed. Without insurance coverage for TG <500, AMRN is not going to see widespread coverage.
"Indications and Usage for Vascepa. Vascepa® (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia."
I take Vascepa without taking a statin. My cholesterol numbers were fine while my Triglycerides were out of control. I went for a period of time without Vascepa after my physician quit practicing so I had to find a new physician and go through the process of trying other things first. After the first blood test with Vascepa, my physician was very surprised and stated that I had a marked improvement in triglycerides and that she was thrilled.
I do wish Amarin would start a trial without statin for those who just have triglyceride issues. I currently do pay out of pocket and have no issue affording it but I know that is not the case for others who would like to take it.
That is an older video from when the FDA approved Belviq.
NAVB finally looks ready to move.
How would you know Omthera has to do an outcomes study when they have not yet filed an NDA? Do you work for the FDA?
"...with our newly established sales force and commercial team. We may need additional capital to support this launch"
Wasn't the same language in the preliminary proxy statement from AMRN which was posted on 3/25?
It looks like VVUS is paying back a minimum of 25% of sales. Isn't AMRN only 10%?