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Has anyone read this? Just wowww!!
Intercept: History May Repeat Itself $ICPT
Sharinky, thanks for that response!!
RR
I'm in the BB camp. I really think this board severely undervalues AMRN. IMO, 3 digits are a year and half away! Big Shit coming down the tubes! JT not wanting to show his cards ie 350 mil. JT is buying time IMO. I love his strategy.
RR
No, resistance was @ $22.77
RR
always,
I'm not a doctor, but those numbers are terrible.
IMO, you probably should be taking a statin + Vascepa and maybe 10mg Ezetimibe. That's what i'm taking.
JMO,
RR
mrmain,
75% $115 4/20/2020
Thanks VuBru...
I remember those charts being posted 100 times after my post. Cajun brain fart.
RR
I remember JT making a statement at a recent conference (can't recall which one after AHA) that "after being on Vascepa for one year, you can really begin to see the separation".
Can anyone with knowledge of that statement explain what he meant by that?
Thanks in advance,
RR
Here's a story on Yahoo of a woman that had a heart attack and didn't recognize her symptoms. Seems a good place to introduce Vascepa in the comments section.
https://www.yahoo.com/lifestyle/womans-muscle-strain-ended-heart-attack-194453498.html?bcmt=1&guccounter=1
Whal...not a Federal employee or retired, I work for an oil company. I've been with the same company for over 12 years now, I couldn't ask for better coverage. Even though my trigs are between 150-160, I suspect being i'm on statins, my insurance didn't question my cardiologist decision to prescribe V off-label.
RR
I'm due for refill 1st of February, I doubt anything will change. I'll let you know.
RR
Yes, I suppose so. I have a really good plan, and I'm grateful.
Whal, I'm with BCBS of Texas....I pay $76 bi-monthly for me and my spouse.
RR
Sonam,
Sorry, I misunderstood. Not an NSAID, I'm currently on statins.
RR
Sonam,
All my prescriptions go through CVS/caremark and my insurance covered V with no questions asked. I used the coupon and it cost me $9 for 3 month supply. And yes, I got it off label.
I went through Walgreens, and without the coupon it would have cost me $35 p/month with insurance.
RR
CBB, I wasn’t aware of that group having the better results, but I fit into that group and I’m definitely feeling some positive changes. I don’t think my lab results in April will tell the whole story, but I’m anxious to see the results.
Almost time to see my Saints whip up on the Bucs, enjoy your day, and thanks for the reply!
RR
dukesking, I’m still awaiting my lab results after being on V for a month. I’m not sure what to expect if anything after only 1 month on V. But I’m scheduled for more lab test in April and a visit to my cardiologist. I’m anxious to see the comparison of lab results in April. You’re welcome...
RR
ilovetech,
The maximum dosage for atorvastatin is 80mg. I have no idea of how side effects correlate to dosage strength, but logic tells me it increases with higher dosage.
You're welcome...
RR
dukesking, I had noticed muscle deterioration over the years since I began statin therapy. But since starting on V and upping my dosage of CoQ10 to 200mg p/day, the improvements in the overall way I'm feeling and the effects it's had on my muscles are just staggering to me. As for the 5-6 lb. weight gain, I'm not eating any more or less than before. It could be the V or a combination of both. Because of the info I've read on the importance of CoQ10 in the muscle tissue, I just assume it's the CoQ10. My energy level hasn't been this good in years.
RR
ilovetech,
I've been on statin therapy since 2013, dosage upped to 80mg in 2015 along with 10mg of Zetia. I began taking 100mg p/day of Ultra CoQ10 about that time without knowing the true benefits other than it was good for heart health. I had joint and muscle pain that I attributed to the statin therapy and complained to my doctor. My cardiologist took me off the statins for 2 weeks to seen if the muscle and joint pain would go away (I think I had stopped taking the CoQ10 for 2 weeks, also), which it didn't.
I think 4 weeks ago I questioned this board on the benefits of taking CoQ10 and was given lots of informational links and personal experience taking CoQ10. From the information I read, 100mg p/day of CoQ10 was insufficient for me.
So, almost 4 weeks ago I upped my dosage of CoQ10 to 200mg p/day. What I am noticing recently is almost shocking. Yes, I have gained 5-6 lbs. in the last month, but most shocking is my muscles in my arms and chest are bulking up, my energy level is much improved, and the joint and muscle pain has improved greatly. It's apparent my CoQ10 levels were severely deficient....80mg statin is high dosage.
One simple question to this board has helped improve my health and well being, and I definitely can tell and feel the difference. When I had asked my Cardiologist about me taking CoQ10, he said I could take it if I wanted. With the help of CBB and others here, I now know what the benefits are and I'm seeing the results. I feel like I've been pumping iron in the gym lately....results are shocking!
I also started on V Nov. 2nd.
RR
marzan, stealing us cheap will never happen. That's exactly the purpose of executing the "poison pill" via Citi.
JMO
This from an Endpoints News email I just received. It cost $599 to see his report...ouch:
Benefit from extensive insight while there's still time
Matthew Maryniak, president of FENIX
Matthew Maryniak, President of Fenix Group International
Twitter | LinkedIn
Recently, Amarin presented REDUCE-IT results at AHA. Although there has been a large volume of news and interpretation on the potential for REDUCE-IT to be practice-changing in preventive cardiology, there has been even more talk about Amarin as the hottest take-out target in the industry, despite the growing short interest post-results.
In this original research report, FENIX provides a winners-losers-and-suitors analysis, including the rationale and context for why Amarin could be bought by top suitors before REDUCE-IT’s FDA approval, why popular choice suitors would NOT be interested, how the current regulatory environment works in Amarin’s favor, and what an updated Vascepa label could look like.
This report is the advanced read that separates itself from all the other REDUCE-IT trial-related analyses you’ve already seen, covering the Amarin market opportunity from the perspectives of Amgen, Sanofi, Novartis, Merck, Lilly, BI, Janssen, Novo Nordisk, Pfizer, Gilead, Esperion, and The Medicines Company.
Section headings from inside the report include:
The top Amarin suitors
Popular choices that don’t quite fit
Loser: AstraZeneca
Esperion and The Medicines Company could be affected
What about…
Dark horses
Other relevant thoughts
The US regulatory environment is highly favorable to reward innovation in cardiometabolic disease
Take action now knowing the full scope of the opportunity and the implications it has on the market.
Get the Analysis
sts66,
I appreciate the information. It’s apparent the 100mg/day I’ve been taking is not enough. I’m going to up my dosage to 200mg p/day starting today.
Thanks for your response!
Bangtime, thanks for that link!
north,
Are you also taking a statin? I’m only taking the recommended dosage of (1) 100mg capsule of CoQ10 per day.
I would be a bit hesitant to complain of muscle aches or joint pain at this time due to my Card agreeing to prescribe me V at the beginning of this month. My joint pain is not constant and for now I tolerate it. I want to see in the months ahead if V can help alleviate this symptoms.
Thanks massulo
stockboy, thanks for the info...
My next scheduled visit is in April ‘19, I’ll ask if that is possible. Maybe by then The V will have relieved the symptoms.....hoping.
Thanks!!
The pain began at some point after starting the 80mg dosage. I started at 20mg, then doubled to 40mg, then doubled to 80mg and my LDL only came down to 90. My Card wanted it below 70, so he started me on Zetia + 80mg statin. That got me down to 60. I doubt he will agree to cut my dose of statin back down to 40mg.
Thanks rose, it doesn’t seem to have helped much for me as for as myalgia goes, and maybe it has and my 80mg dose of statin is just a case of benefit outweighing the discomfort. The joint pain isn’t continuous, and can last for several days, but it always seems to be at the surface and can strike at anytime. If it helps to protect LDL from oxidation, then that’s a real benefit of which V should do the same. I’m going do blood work this Thursday, which is only 26 days into starting on V, I’m a bit anxious to see if I’ll have any change in my results so soon.
rr
Thanks for your response JL. Any added benefit is worth it for me. I had complained to my Card earlier this year that my arm was falling asleep at night (because I have a habit of sleeping with my are fully closed) and I thought maybe the high dose (80mg) statin was the cause. So he had me quit taking the statin for 2 weeks to see if that issue would go away, and it didn’t. So I resume my daily statin intake. Since I started taking V on Nov, 2nd this year, I realized last week that I couldn’t remember the last time my arm fell asleep.....cause it was almost an every night ordeal.
I appreciate all of what you post JL, very much! My interpretation of medical abbreviations, and overall understanding is lacking, but in time I’m able to put 2 and 2 together in simple form. It’s a real personal experience for me being here and trying to educate myself.
Thank you,
rr
Massulo,
That’s just it, my Card saying “I could if I wanted” left me right in the middle. So for me, any added benefit by taking it, I was willing to try. But the question has always lingered in my mind....am I just pissing money away. I’ve never heard anything bad about CoQ10, that’s why I decided to pose the question here.
Couldbebetter is taking it and his explanation of benefits is what I wanted to hear. I’m on 80mg statin, btw....a high dose and I feel the joint pain in my forearm and knees at times. Hoping Vascepa can help alleviate that joint pain in time.
Thanks Massulo,
Geaux Saints!
cbb, that’s very encouraging to hear. I’ve been taking it for 3 years now, I was almost afraid to get off of it unless I found out I was doing more harm than good. I’ve been holding shares of AMRN for a year now, thanks to a woman from the state of Washington who introduced me to Amarin. For months I’ve read this board trying to learn all I could about my own condition. You guys are just the fukin bomb when it comes to science and medicine......I’m sure my questions seem dumb, but I don’t have a problem owning them if the answers ease my mind. I really appreciate all of you.....
Thanks much,
rr
I’ve been taking V since Nov, 2nd this year. My Card has me scheduled for blood work on the 29th. I had asked my cardiologists a couple years ago if it was ok for me to take CoQ10 and he said I could take it if I wanted to, but I never really understood the benefit. I was a mere 50 years old when I had my CVE, scared the hell out of me. So anything that could add some benefit, I was willing to try. But I’ve never had any definitive answer as to whether CoQ10 was a real benefit to me. And now that i’m on V, I want to make sure the CoQ10 is now having a negative effect on the benefits of V.
I don’t like taking any medication in excess. Just wish I knew for certain if I was getting any benefit, if not, it would seem a waste of money.
Massulo, I really appreciate your response.
Thanks,
RR
JL,
I’ve learned a lot about myself from you and many others here, still a dummy when it comes to medicine. But I have a question I’m sure you can answer.
I’m currently taking Atorvastatin, Ezetimibe, 81mg aspirin, and Vascepa.
I’ve also been taking Qunol Ultra CoQ10 for the past 3 years now. What are your thoughts on taking CoQ10? Is there any real benefit to me taking it? Or am I just wasting my money? TIA
RR
By invitation only....
RR
Invest83..............I posted this on the 14th.
What’s coming? Pazdur, Marks and Woodcock discuss FDA changes
by zachary brennan - rapsenvelope — on November 14, 2018 03:48 PM EST
Updated: 03:49 PM
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Three of the FDA’s directors — Richard Pazdur, Peter Marks and Janet Woodcock — took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA: from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers.
CDER director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is that there has been a sort of scientific revolution, with biology being harnessed in novel ways and investments at NIH paying off.
Richard Pazdur
Oncology Center of Excellence director Pazdur also noted the tremendous growth in understanding diseases and in the immunology of cancer.
“One part of the piece in oncology is that our staff has embraced these changes,” he said, noting they’re “not just bean counters for survival data” but have gotten involved in the science of oncology. The staff are partners in the process rather than just ticking boxes, he said.
And Marks, director of the Center for Biologics Evaluation and Research, explained how the idea of screening libraries of compounds has gone out the window, while nowadays it’s more about rational drug development – “and gene therapy is the epitome of that.”
On the topic of gene therapy, Marks noted there are now 700 investigational new drug applications before FDA. But compare that with cell therapies, he said, noting a gray market of unproven treatments, which in some cases are nothing better than badly manufactured snake-oil that don’t contain live cells. He also said the use of unapproved stem cell therapies around the country is a surrogate marker for how Right to Try may play out. FDA doesn’t usually learn about what is going on until something really bad happens, Marks added.
On the prospects of what’s to come at FDA, Woodcock noted the real-time review pilot in the Oncology Center of Excellence, which reviews parts of a submission before the entire application is submitted, is “foreshadowing something bigger.” But she also explained how the speed of reviews does not really influence the results, saying: “what has changed is the cost of these drugs, and it’s changed the debate because of value.”
Nowadays and moving into the future, there’s a societal benefit and harm discussion that implicitly invokes “trade-offs in value – that’s the new debate we’re having – too fast and too slow is really not the issue.”
For Marks, the biggest problem moving forward for gene therapies is the quantum leap needed in manufacturing and to applying the techniques beyond just rare diseases. “We need to do the kind of transformation Steve Jobs did for digital,” with manufacturing gene therapies. He also noted FDA is “very lenient” about some of its manufacturing standards for getting gene therapies into Phase 1 trials, but scaling up the manufacturing is what’s difficult.
Moving into the future legislatively, Woodcock said she’s interested in legislation on generic drug labeling. “We have to clean up the armamentarium so it doesn’t get out of date,” she said. She further noted FDA is working with Congress on over-the-counter drug reforms, which is the basis for the Office of New Drug modernization. “If we don’t get the OTC reform, we’ll have to pull back on the OND reforms,” she said.
Image: Janet Woodcock
First published here. regulatory focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.