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You can substitute the word "sharing" with the word "stating". It'll make more sense.
Zip, forgot about SEC. Harry Markopolos handed Bernie Madoff's ponzi scheme evidence five separate times to no avail:
http://www.cbsnews.com/news/the-man-who-figured-out-madoffs-scheme-27-02-2009/
All government agencies are worst than useless. They makes life difficult for law abiding citizens while the bad guys pretty much get away with various crimes. You name it, FDA, EPA, IRS, CDC, DMV, SEC, etc.
Where is Ladavis when you need him?
Z, did you mean lower Trig and not LDL?
HG, end of 2014 cash balance would be @ $120M assuming Q42014 cash burn of $15M. End of 2015 cash balance would be @ $80M if 2015 cash burn were $40M. Stock should start to run up in 2015 anticipating a successful 2016 interim analysis. JT might not be the sharpest or best talker but he is a bean counter by trade. Hope you got this Mr. Ladavis.
Thanks. I'll look into it.
STS, what's the best brand for coq10? TIA.
Dew, thanks for the explanation. Do you think if a REDUCE_IT trial patient suffer a soft event, he or she would have to leave the trial? TIA.
JL, thanks for the insight. I just hope the actual event rate is higher than 5.5% for the placebo group. Otherwise, the more efficacious Vascepa is , the longer it would take for R-I to reach interim analysis.
Does Dew or anybody know if once a patient trigger an event, would he or she be kicked out of the trial pool? If yes, then the trial pool would consists of patients who are less "sick" as time goes by. As a result, the ongoing event rate would be lower than the initial projected event rate.
BB, that's a great point you raised regarding the new policy. Did you communicate that to Amarin. According to Ajax, Amarin management are not the sharpest guy in the room, right? TIA.
slightly off topic,
http://www.cnbc.com/id/102068233#.
CJR, thanks so much for your feedback from IR.
What's Mike contact phone number?
I tried to call Amarin's IR phone number and dialed by directory using Mike's last name and still can't locate him. TIA.
Vascepa is not a combo drug so the new policy probably won't apply.
What about Ms. Parks' involvement?
Ezetimibe lower LDL but it failed its outcome trial.
What I try to say is that statins gave Mr Russert and his doctors a false sense of security thinking as long as LDL is under control, everything would be fine. In actual fact, his rising TG before his untimely death might be the true warning sign.
Tim Russert's LDL level was 68 and his TG level was very high when he passed away at 58 years old,
http://livinlavidalowcarb.com/blog/tim-russerts-fatal-heart-attack-was-preventable-he-followed-antiquated-advice/2403
How many more Tim Russert FDA is willing to sacrifice before REDUCE-IT result?
AK, do you know how many unpleasant and probably harmful side effect brought by taking max dose Crestor. Please don't dish out medical advice in such a cavalier way. I think minimum acceptable dose Crestor + Vascepa is a much better way to go for most folks. As we all know (except FDA) 1+1 =3 for Vascepa/statin combo.
I hope IMPROVE-IT will fail its outcome study come November,
http://www.forbes.com/sites/larryhusten/2014/10/02/cholesterol-drugs-haunted-by-ghosts-of-past-present-and-future/?partner=yahootix
I am going to research a bit about James Gandolfini and Jim Henson's fatal heart attack. There's probably more famous people I can't think of for the time being.
Note that in the middle of article, it said,
" triglycerides (something Russert dealt with having too high over the past few years)"
If true, TG might be a much better biomarker than LDL (Akanz pls take note). All the indicators seems to line up for a successful R-I trial: Jelis, subgroup analysis of HDL trials, multiple independent genetic studies and now this.
Interesting article about Tim Russert's death due to heart attack,
http://livinlavidalowcarb.com/blog/tim-russerts-fatal-heart-attack-was-preventable-he-followed-antiquated-advice/2403
DD, thanks for the feedback. I am shocked NEPT do not follow ACST's down move. I remember JL had discovered certain trial data discrepancy published by ACST last year.
ACST announce Phase II results,
http://finance.yahoo.com/news/acasti-reports-successful-capre-r-120000479.html
Headline looks good but ACST stock tanks and AMRN stock shoots up.
Does anybody see anything -ve on its data.
HD, will the following proposed new guideline,
https://www.federalregister.gov/articles/2014/07/15/2014-16374/confidentiality-of-interim-results-in-cardiovascular-outcome-safety-trials-public-hearing-request
if passed, has a negative implication on REDUCE-IT's upcoming interim analysis? TIA.
AK, did the APOC3 genetic studies and THRIVE already disprove HDL as a valid bio marker?
AK, did the APOC3 genetic studies and THRIVE already disprove HDL as a valid bio marker?
What you talking about? Can you start the countdown after it closes below $1 for 30 straight trading days?
I like the part,
"Ex-U.S. Markets: Increase level of priority, consider strategic options", most in the updated presentation.
JT's quoted statement doesn't reconcile with Ajax's. JT said he tried to compromise with the FDA over last 10 months but Ajax said JT refused to compromise at all.
Good for labor day weekend. We should get over 10K Trx next week.
For those who are off statin, your LDL will probably go higher in your next blood work results as Vascepa mainly lower TG.
Is that true? Amarin did a secondary @ $5.6/sh before ADCOM last year but after the Pharmakon loan.
Chab, I agree with you.
I was watching the price action. Volume and price started to tick up strongly @ 10:30 am. Then came the SR OONDD twit @ 10:50am. We all know the FDA is full of leak. AF heard it couple weeks ago and today's price action confirms it, IMHO. The stock price also breaks its 200-day moving average on 3.4 times average daily volume today. GLTA.
The Jenkins video is still there.
Ajax, thanks for dropping by.
Always valued your opinions. I know you are busy but 2 last questions from me:
1) FDA was willing to compromise back in January. They certainly should be even more willing to compromise now given the pressure the FDA is under, i.e., more positive scientific studies and political pressure. Right?
2) What exactly Amarin had to give up during the January compromise discussion with the FDA for ANCHOR approval?
TIA.
Mineral oil would only be an issue if the placebo event rate were significantly above 5.2% which I doubt. If R-I indeed got a higher event rate then we reach interim (967 events) even earlier, which is a good thing.
Red, no mention of Cardio background for Jenkins:
Biography for John
K.
Jenkins, M.D.
Dr. Jenkins is currently the Director of the Office of New Drugs, Center for Drug
Evaluation and Research, Food and Drug Administration. Dr. Jenkins received his
undergraduate degree in biology from East Tennessee State University in 1979 and his
medical degree from the University of Tennessee at Memphis in 1983. Dr. Jenkins
completed his postgraduate medical training in internal medicine, pulmonary disease, and
critical care medicine at Virginia Commonwealth University/Medical College of Virginia
from 1983 until 1988. Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary
Diseases by the American Board of Internal Medicine. Following completion of his
medical training, Dr. Jenkins joined the faculty of MCV as an Assistant Professor of
Pulmonary and Critical Care Medicine and as a Staff Physician at the McGuire VA
Medical Center in Richmond. Dr. Jenkins joined FDA as a medical officer in the
Division of Oncology and Pulmonary Drug Products in 1992. He subsequently served as
Pulmonary Medical Group Leader and Acting Division Director before being appointed
as Director of the newly created Division of Pulmonary Drug Products in 1995. Dr.
Jenkins became the Director of the Office of Drug Evaluation II in 1999 and served in
that position until he was appointed to his current position in January 2002.