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STS, have you try Qigong to imrpove your health?
HD, thanks for the detailed analysis. Just one disagreement about the statement "App 3,000 patients were enrolled with TG 150-200". It should be between TG 150-500 as I thought Amarin had indicated the median/mean TG of the first 3000 patients is around 200.
Like it or not, the market thinks the probability of R_IT success is far less than the probability R-IT failure. We, die hard Amarin long, are having a contrarian view on the prospect of Amarin stock. Big money is made when one's contrarian view turns out to be correct. Much effort and energy on this board should be spent on validating our contrarian view, IMO. Once we have won the NCE and 1st amendment lawsuit, all other issues seems insignificant compare with R-IT success.
HD, when R-IT reaches interim in 2016, we need 645 more events (1612-967) from 7033 remaining patients(8000-967) within 24 months (probably closer to 22 months or less) if Amarin wants to finish the trial before the end of 2017. Your 4.38% composite rate assumption seems a bit low. Have you come up with a new composite rate since the last earning call?
Does anybody know if the Kowa partnership is exclusive? Based on the script performance since the commencement of the partnership in April 2014, I would fire Kowa by now for non-performance. It doesn't even list Vascepa on its product website. That's not a good partner, IMO.
http://www.kowapharma.com/productCore.htm
JL, slight disagreement on two points:
1) full ANCHOR approval guarantee insurance coverage between 200-499.
2) full ANCHOR approval would have ANCHOR data on label hence requires much less effort marketing to clinicians.
It seems like Vascepa foreign rights are low risk/high reward way for foreign pharma companies to get on the Vascepa train. A Korean or Mexican or Brazilian pharma companies can just take a chance paying 15-20 million upfront. If R-IT proofs successful, the returns could be many times the upfront payment. I hope JT will only strike a foreign deal if the term is very attractive. He might not strike any deal near term if he is truly very confident about R-IT.
BTW, it's 5 months not four months.
Don't worry about investor case. It has zero effect on the future of Amarin.
Any talk about BO on this board is a total waste of time. It's akin to what happen if I win the lotto tomorrow. The most important thing right now is to try to figure out the probability of R-IT success based on info. company provides and any relevant research we can dig up. Are we sure the placebo group event rate is at least 5%? If not, we might have to dial down the probability of R-IT success.
Anybody know of any peer reviewed scientific paper linking the benefit of EPA on DES? Those info., if available, should be considered truthful and non-misleading.
A nice ADCOM summary,
http://www.sac-tracker.com/promo-vascepa
AP, if you are long AMRN, then you must be the most pessimistic long I know, even more pessimistic than Kiwi and freak69. I hope your ESPR investment is treating you well.
JL, hit the ihub post limit for the day. Just to make sure to reply back to you @ 12:01am. To get behind the paywall of the medscape article:
1) google “diabetes trial event rate”
2) the medscape article is the 4th or 5th item on the list. It’s called “Review of Event Rates in Diabetes Clinical Trials – Medscape”
I think it’s relevant to R-IT trial.
"it is an unusual case in which the company did have evidence in support of the use they wanted to promote. " Why that's a lie?
One more catalyst next Friday, Vascepa NCE on OB.
Can we once and for all conclude that there's no leak from both Honorable Judge Moss and Judge Engelmayer? Those who doubted the integrity of the judges please apologize.
Might have posted before. It has a good discussion of event rates of diabetes trial, especially table 4. I believe those trial events are based on hard MACE while R-IT's events are based on soft MACE which is an advantage for R-IT success.
http://www.medscape.com/viewarticle/735001_3
Thanks drrc. Kiwi is also known as Akanz2 and Gary. He is certainly a man with many nicknames.
The best article I have read regarding our 1st amendment victory,
http://www.washingtonpost.com/news/wonkblog/wp/2015/08/07/fda-barred-from-restricting-companys-promotion-of-fish-oil-drug/
STS, please tell that to KIWI.
aqxp has a float of 4.7MM while AMRN has a float of 147MM, apple and oranges.
Here is the full 71 pages,
http://www.nysd.uscourts.gov/cases/show.php?db=special&id=478
Thanks to greenday again,
https://twitter.com/greenday_bio/status/629670202792374273/photo/1
I like this one:
"The Court's ruling also permits communication to healthcare professionals of the following information:
peer-reviewed scientific publications relevant to the potential effect of EPA on the reduction of the risk of coronary heart disease, such as the JELIS cardiovascular outcomes trial of a pure-EPA product in Japanese patients and other publications on omega-3 acid studies; and
more complete efficacy data from the ANCHOR trial."
$2.15 seller gone. Blue sky ahead.
Thanks for greenday,
https://twitter.com/greenday_bio/status/629654871973740545/photo/1
Imagine PFE, MRK or AZN sales force get in hold of such claim. Vascepa to the moon.
Don't you think they know already? Timing of the PR is immaterial.
Right is on our side after all. NCE, 1st amendment right, R-IT success...
I clicked the reply to you by accident. I didn't attempt to address your question.
HD, your 4.38% composite rate assumption seems a bit low. Can you re-calculate your number again ? TIA.
Kiwi, why you keep yelling fire in the theatre? With additional foreign rights available for sale, the backing of BB and no generic competition until July 2020, Amarin's staying power is no longer in doubt. Remember JT is a bean counter by trade. Amarin should have at least $100MM @ year end 2015.
When R-IT reaches interim in 2016, we need 645 more events (1612-967) from 7033 remaining patients(8000-967) within 24 months (probably closer to 22 months or less) if Amarin wants to finish the trial before the end of 2017.
JL, BTW, 970/23000 = 4.22%. However, you are the best in explaining a complicated concept. Even a layman like me...
JL, thanks for the detailed calculation. HDG had calculated that for the interim to be in 2016 and the 1612th event to be in 2017, the composite rate is expected to be around 4.38%. I'll try to use your approach to see if I get anything close to HDG's estimate.
HD, JT said in the conference call, "the cardiovascular event rate continues to track to our expectation for the protocol's pre-specified interim efficacy look by the IDMC in 2016". Based on your previous calculation, that means the composite event rate of R-IT is tracking @ 4.38%. So the big unknown is the actual placebo group event rate. As long as the placebo group event rate is greater than 4.75%, R-IT trial will be a success, right?
Do you mean cooperation instead of corruption?
JT sounds upbeat in the CC and provide more color on R-IT. I guess management has read my email request.
I have emailed IR requesting more detailed update on the progress of R-IT from Steve Ketchum. We'll see what happen.
I am just thinking the opposite. FDA didn't appeal the Caronia ruling.