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Congrats to you Chica. I believe the stock just gone up 2 cents due to your 1-yr Vascepa script. GLTY.
STS posted this earlier :
"Jenkins pointed out the logistical difficulty of going back and re-visiting previous approvals. A system that required the agency to revisit every prior decision as science evolves and standards change would make the regulatory process impossibly cumbersome and burdensome on both the agency and sponsors of approved indications.”
The same Jenkins that Amarin is appealing to now!
Does anybody know once an enrolled patient get a MACE in the R-I trial, will he or she be taken off the trial after appropriate medical treatment? The answer to the question could impact the total MACE event number, right? TIA.
James Gandolfini, Tim Russert, John Henson and countless other celebrities and Americans died way too young due to heart problems. Vascepa could have helped prolonging their life and certainly wouldn't hurt.
http://www.nbcnews.com/health/mens-health/gandolfinis-sudden-death-all-too-ordinary-f6C10393639
I am truly ashamed and saddened that FDA is more about hidden agendas and paying back BP favors than saving life.
HDG, best post of the year. Any neutral thinking person should see thru FDA's motive. Would you be kind enough to post this on biobill's CP. TIA.
Ajax,
Not true :
Based on Amarin's breifing doc. and quarterly CC, I constructed the following RI enrollment data :
Date # of Enrolled Patients
5/9/14 6800
2/27/14 6500
10/4/13 6075
7/4/2013 5535
4/4/2013 4451
1/4/2013 3043
10/4/2012 1756
7/4/2012 575
4/4/2012 108
I tried to estimate the number of events to date based on 5.2% annual event rate and having a hard time. You guys are welcome to try.
They only enroll patients with TG>150 and then changed it to TG>200 later. By definition, the mean should be north of TG>150, no?
Bio, Epanova will start listing on the June OB but I can't imagine the new patent code would apply to Epanova.
How many of these deaths Vascepa could have been prevented/postponed?
http://www.slate.com/articles/life/culturebox/2014/06/death_map_the_most_common_causes_of_death_in_each_state_of_the_union.html?utm_content=buffer1ba05&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
Bio, invoking Jenkin's memory of Vioxx will only make him more cautious and result in not approving ANCHOR for a large patient population.
Why the name calling? Be an adult please.
PFE's dropping of its bid for AZN is a clear positive for AMRN, IMO. According to WSJ, "Mr. Read said Pfizer would look at deals that would strengthen its core areas, including vaccines, cancer, inflammation, heart disease and pain. He said Pfizer was open to transactions of all sizes and was interested in deals that would bulk up the company's two main segments: new, patent-protected medicines and older products that are losing or have lost exclusivity."
I believed PFE hired an Omega-3 expert few months ago. It is clearly interested in what Amarin is working on.
Based on Amarin's breifing doc. and quarterly CC, I constructed the following RI enrollment data :
Date # of Enrolled Patients
5/9/14 6800
2/27/14 6500
10/4/13 6075
7/4/2013 5535
4/4/2013 4451
1/4/2013 3043
10/4/2012 1756
7/4/2012 575
4/4/2012 108
I tried to estimate the number of events to date based on 5.2% annual event rate and having a hard time. You guys are welcome to try.
AK, just to mention a few points :
1) EU rights for Vascepa to a BP such as GSK worth something.
2) Irish street address for tax inversion worth something.
3) Probability of success or expected value of R-I trial worth something (30% expected success rate of a billion dollar drug still worth several hundred million dollars).
Amarin is not as desperate as it seems.
If it's on Hamburg's desk, that means Amarin lied again during conference call.
That's after generic Lovaza been killing GSK's L sale. Great job FDA and what a great timing for your buddy GSK!
Navy, will this tailwind becomes headwind when Obama left office come 2016? TIA.
STS, you said "A few posters here are privy to what Ajax did in the background and how he did it". With all due respect, seems like you are you are the only poster here that agree with what Ajax proclaimed. I could be wrong but I just can't think of any other posters.
STS, what made you so sure of Amarin's management "refusing to renegotiate the SPA and ANCHOR label"? TIA.
Ajax, all Amarin wants is to market V for TG >200. What you stated is not a compromise at all as far as FDA or Amarin are concerned. Your side of the story does not add up.
Ajax, thanks for the info. While you are here, would you please describe, once and for all, what did the FDA offer to Amarin as a compromise during the MLK weekend negotiation. TIA.
BioChica, it's very encouraging to see the effect of generic Lovaza on Vascepa is minimal. The prescribing physicians, rightly so, view them as totally different lipid lowering drugs.
That's not true at all. REDUCE-IT is our only hope.
15%. Google REDUCE-IT trial for detail.
Biobill, does Mochida own Epadel already? It might not need Vascepa for the combo.
According to Homebuilder of atocktwits, for week ending 4/11/14 :
Vascepa TRx 6,915 v 6,836 up 1%. NRx 3,164 v 3,127. Lovaza TRx 78,517 v 83,721 down 6%, NRx 31,291 v 30,758 up 1.7%
Interesting video about TG, HDL and LDL starting at 36 minute mark :
Dude, high TG/low HDL sub-group in VA-HIT, ACCORD and AIM-HIGH studies not enough evidence for you? I thought THRIVE already failed its outcome study :
http://www.medscape.com/viewarticle/776483
Can you believe the baseline medium TG for THRIVE trial patients are 103 mg/DL?
STS, FDA rescinded ANCHOR SPA on 10/29/13 while FDA's label re-wording offer, if true, happened around Martin Luther King weekend according to Ajax.
Ajax, why didn't Thero just take his $150K bonus by agreeing to the modified ANCHOR label? He could have looked like a hero, declaring victory under his watch and further solidifying his CEO position. Any educated guess. TIA.
Interesting info. on past fibrates trials :
http://www.medscape.com/viewarticle/555407_7
Purified Fish Oils Could Help Treat Rare Disease Affecting Newborn Babies :
http://www.redorbit.com/news/health/1113095052/purified-fish-oils-could-help-treat-rare-disease-affecting-newborn-babies/
PCSK9 has a problem :
http://news.investors.com/technology/030714-692498-regn-stock-falls-as-alirocumab-under-scrutiny.htm
And Coleman said PCSK9 has no need for CVOT. He is a total joke.
JL, thanks for your insight.
JL, does it mean Crestor prevents CVD better than Lipitor and Zocor?
And patients taking Vascepa together with Crestor won't benefit as much as those taking Vascepa together with Lipitor or Zocor? TIA.
Do you guys agree with the fool's fair value estimates of the common :
http://www.fool.com/investing/general/2014/03/03/fannie-and-freddie-what-is-the-true-potential.aspx
I can't buy any more FNMA & FMCC common stocks @ Interactive Broker.
Interactive Broker told me it's because DTC is no longer the transfer agent for the common stock. Anybody has IB as broker and has the same problem. TIA.
It has nothing to do with cash. Interactive Broker told me it's because DTC is no longer the transfer agent for the common stock. Anybody has IB as broker and has the same problem. TIA.
I am not allowed to buy FMCC common stock in my Interactive Broker acct., despite having available cash. Anybody encounter such a problem. TIA.
If REDUCE-IT is successful, it'll prove Vascepa could save life. If FDA still won't approve ANCHOR then, what's the point of having FDA.
If a person walked all over you already and treated you like manure, do you still worry about establishing "bad blood"?