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Practice patterns change over time. I’m sure there’s no hard cutoff. He’s just providing a rough example.
So usually prescribers don’t check before writing a script. However , some do. Majority of cases what happends is they write it , pharmacy calls asking if they can substitute it or change it because insurance won’t cover it. Moving forward physicians less willing to prescribe it because of the nuisance in the past.
So I think over time this will translate to many more scripts but won’t happen immediately. Will take time like everything else with amrn ha.
Well said. To add, Flubb, I think it revolves around many of us have spent so much time researching amrn and knowing it for 8 9 years. WS (and I have friends at 2 firms) tell me that I know more about this stock than most on WS will ever know about a single 1 stock. Some of that is being a physician. I’d say some on this board know more than me for sure as well. WS cannot obsess about 1 stock like we can. We know every little nuance to this stock and mainly the science. My bet is on the science aNd the PPS will follow eventually.
GLTA
Its massive. Congrats on being in that from the ground level. Massive market. nice buy. I didn’t buy phas in time bc I didn’t think it would get that spike this early in the game.
Thanks. Appreciate it
BO PRice- anyone understand BO price better than me ? I’ve watched a couple now and it seems the stock never gets to the BO price. Example APC bought out for 65 bucks and it’s trading at 60-61.
Yeah. See below second paragraph.
Ideally check with your accountant before doing so if your taking money out early.
If the withdrawal is made before age 59½ and doesn’t exceed the amount that has been contributed to the Roth IRA over the years, then no income tax is charged. As stated earlier, withdrawals of contributions are tax-free.
If the withdrawal is made before age 59½ and includes earnings, then you may have to pay both income tax and a 10% penalty. There are certain situations under which the IRS will allow you to withdraw without penalty, however. Funds can be distributed for higher education expenses or to buy a home. Certain hardship circumstances, such as permanent disability, also allow funds to be withdrawn tax- and penalty-free
In a Roth IRA your not taxed.
How many of these cases go no where and no class action is eventually filed? Probably a lot.
This case has no merit. If they go through with it there’s no case and no money to be made.
Just my thoughts. Thanks for your post.
Hm I never entertained the idea that they don’t have it. Your point is a good one but let’s hope they have it For sanity sake.
Hah love it.
Yeah. I still get stuck on some details bc of how many drugs followed suit in the statin market. Appreciate you and the others that have weighed in (Jl chas raf).
As far as the financing, agree that’s a lot of money. They stated it will take them well into 2021 so long enough to run their trials.
I still think the epa blood level issue isn’t a dead argument. If we know TG> 150 and <150 benefited the same and amrn publishes data to suggest those with a certain epa/aa ratio benefited the most, that could become the new target marker as TG clearly is not the best marker. This won’t happen tmw but I’m saying it could happen down the road. We have to entertain that idea. Qs is whether fda will buy into it and allow that to be the marker with head to head studies and not outcomes study. That’s the basis of all my posts lately.
I asked amrn IR this and some other issues now twice. They seem to know a lot about the competition which is good but don’t see it as a “threat yet” for much of the reasons that have been stated. They defended Vascepa quite well. They also said they expect to publish more data from reduce it but dodged my question as to why epa/Aa data hasn’t been released yet when they have that data. They are aware MTNBs study was flawed so they are not blind to the competition. Also, in terms of MTNB even in best case scenario they won’t be ready for approval until 2023 although I think their end of 2020 trial is something to watch to see if it replicates their small flawed trial. Hopefully doesn’t.
The only other risk is ITC. Did that judge die? I can’t believe there’s no decision on that yet and now the smaller court put a motion to await the ITC ruling bc it will influence smaller court ruling. I think and hope we win ITC case. ITC means less with the ADA guidelines EMA statement and multiple other reasons but I think these issues need to be put to rest for BP to come in and take us out.
Lastly, I asked IR about why they won’t include ongoing trials in any of their talks presentations (ever) etc and they said they are focusing on cardio first and putting all their attention there. I still think they should “pump” their stock a little and mention the ongoing trials for dementia Nash cancer etc.
Done rambling.
Fair enough. Thanks.
I strongly disagree but respect your opinion. Time will tell.
I see your point with the OTCs and taking extra but supplement industry is diff. Let’s leave that beast alone until ITC news.
In terms of 0 percent chance they’ll need an outcomes , I would say it’s higher. The problem is if they get labels for TG> 500, even if they don’t get a label for TG under 500 they can steal some market share there based on epa blood level data. If a physician is approached and says reduce it reduced events 25 percent. We have a drug that has better blood levels of the component (epa) Amrn claims was mechanistically likely to have caused such profound anti inflammatory effects, then physicians can prescribe it without CVOT. It’s going to come down to marketing and sales force and whether these small companies team up with BP or not.
One other point, if we get priority review (which we should and I think it’s crazy JT keeps saying he is expecting standard review ), we should be able to get the label quickly and market fast. Our execution is key. Your sales estimates are key. Point being, we need an estimate of sales in 2020.m to really shoot this stock. That projection will be the rocket in the stock price. I’m hoping we can hit > 500 mil this year. Then JT can get early label and give us a massive projection for next year that has to be > billion hopefully more so we can get the ball rolling and explode.
Raf. Trust me I am equally frustrated. I think we prevail. I’m just seeing this as potential threats to look at and be informed of.
Link to the conf call transcript with the two trials end of 2019 is here
Acasti Pharma, Inc. (ACST) CEO Jan D'Alvise on Q3 2019 Results - Earnings Call Transcript $ACST https://seekingalpha.com/article/4241617
I do believe both companies will piggy back the epa levels. The lovaza argument is a lost cost bc they won’t get the same epa levels and have failed outcomes trials.
However for MTNB, with epa and dpa if their biomarker trial succeeds head to head and they get better epa blood levels then Vascepa, They believe they have an avenue for fda approval if you listen to their conf call. If amrn claims a certain epa/aa ratio as the pt population that benefits, and MTNB drug can get the pt population and raise epa levels better that will be their argument. Mind you end of 2020 read out. Also will take few years for approval. Problem is MTNB has people formerly at fda working for them as well as steering committee members of strength trial and reduce it working for them. Very experienced.
As far as ACST, I think they need a strength trial positive read out to be a true threat. If strength trial positive , then they have be able to claim epa levels as the key mechanism. They’re phase 2 trial was against lovaza which isn’t the market leader.
Also remember this is how statins started. So many came to market without outcomes trials. They piggy backed.
Future Competition. - ACST. Reading out two phase 3s end of 2019 for their dha epa krill oil. They claim they did a survey that read
“This was reinforced in our latest market research study where physicians interviewed said that they would switch approximately 68% of their patients to CapRe with triglycerides in the 200 to 500 milligram per deciliter range and 82% of their severe hypertriglyceridemia patients in two years of launch.”
Seems crazy to me. Competition is going right after amrn. They did say they won’t pursue an outcome trial until strength reads out bc they have DHA in their product. They claim to lower a1C and LdL and raise HDL. All biomarker based data. They won’t be able to market until probably end of 2020-2021. However I don’t like how physicians claim they would switch people to this. Who is filling out these surveys!
Meanwhile MTNB also going after amrn now shifting their 30 million capital raise all towards their omega product. Hired a ridiculous management force with lots of experience. Former amgen physician now with MTNB believes they have the better drug over Vascepa. Doing a head to head study against Vascepa due out end of 2020 (this time the correct dosing of Vascepa) and I believe they are going to try to skip an outcomes study and get approval based on EPA levels. My theory is this is part of reason amrn is not releasing that info. If FDA has it, maybe these companies can get earlier approval pathways. I think competitors can claim the same epa blood levels and skip outcomes trials. I know it’s really annoying to read but we have to learn the enemy in order to stay ahead of the curve.
I just spent the last half hour plus looking for it. It’s not anywhere. It was a well done 25 page or so document with graphs and tables of a bunch of questions to physicians regarding Vascepa. I’ll keep looking. weird.
First, you don’t need to be on a statin to get Vascepa. Whether you are on one or not is a whole diff discussion. Probably most will be on one.
Insurance companies will cover it outside of the label. All insurance companies do on drugs currently on the market. Right now the majority of scripts being covered for Vascepa are off label as it is. It just takes time for Ins companies to catch up to the data but it’ll happen.
The more and more we learn about Vascepa and how big the market is the more and more I am thinking we go alone
Impressive Jeffries survey showing 8 percent of physicians to prescribe Vascepa at TG > 75. This is what I have been mentioning in regards to extrapolating data and applying it to the masses. I think that percent is going to go up over time and no one has calculated this in projected peak sales. This is massive.
Thx. Yeah your probably right. Can’t be coincidence. I also just can’t really grasp how no one can understand how massive Europe is alone. I mean twice now EMA has made this statement giving us essentially a monopoly in Europe and it’s like the market doesn’t even react. Everything seems to be coming together except the PPS ha.
Qs. Are we confident the snda includes making the ADA guidelines? They must have had info ahead of time to write it in their report. I just hope it’s in there.
Enjoy safari. You aren’t missing anything here. It was a sell the news event despite how good the data is. No, it did not make tx guidelines yet.
Guidelines - “Data may pave way for inclusion in heart disease treatment guidelines” ACC spokesperson says.
Anyone have access to this ? I’m just curious if anything else was mentioned.
https://scrip.pharmaintelligence.informa.com/SC124924/Latest-REDUCEIT-Results-Bolster-Case-For-Amarins-Vascepa-Fish-Oil-Pill
I was also surprised it didn’t come in the cardio discussion. They have to have this data by now. I am wondering if amrn is holding that info back to not complicate matters with the fda regarding label. They want to keep it straight forward as in Cad or dm risk factors with TG > 150 instead of a certain epa/aa level which would be earth shattering to a mentally incompetent fda. You think there’s any validity to that thought ?
Thank you for that. I will have some wine and calm down now.
Thanks for posting. This paragraph infuriates me. Has she ever heard of a randomized controlled trial. No one would know who was on Vascepa. Her critiques like most that we deal with are pathetic.
But cardiologist Dr. Rita Redberg raised additional concerns, saying in an email that a number of unanswered questions remain. For example, the most common events in the study were coronary revascularizations -- procedures like stents that bring blood flow back to the heart. However, she said this can be "quite subjective and done at the discretion of the investigator without objective criteria."
Agreed. I like your thoughts.
The only caveat with the EPA/Aa ratio is it will require a mass change in lab testing which will take time. Currently everyone has their TG levels and knows their risk factors so it is easy to prescribe off of that even though we know the ratio will be most accurate.
I think your right in that this eventually is prescribed off of the epa ratio but I am wondering if amrn is holding off on releasing info on that because they don’t want to complicate matters for labeling. I can be wrong on this. I am just wondering if they released info on epa/aa ratio possibly the label would have a certain ratio as the target audience which would then delay prescribing as that test would need to be done first. Sounds like an easy test but it’s all about marketing and getting physicians to do that test. Just a thought.
both. Obviously majority was secondary prevention but there was also I believe 30 % primary prevention. We all know the secondary prevention group benefited. This market is enormous. We all know the DM with risk factors benefited which is also a huge huge market. The question is what about those with TG <135. There was no bottom number to which patients did not benefit. Benefits were seen across high and low TG. THIS IS WHERE THE GRAND SLAM IS. How much will physicians extrapolate the data and prescribe this outside the inclusion criteria of reduce it? Will moderate risk pts with TG of 120 110 100 get vascepa. Will all those with hx of cad stents get vascepa regardless of TG level? No one knows so physicians will act in best interest of patient and use what they know about the drug.
I believe it will get mass prescribed like aspirin had been. I had a post awhile back about how aspirin was intended for secondary prevention and got mass prescribed. Nowadays almost everyone takes a baby aspirin. You ask patients why they are on it and they say they don't know.
The ACC 2019 conf is going wild over the fact that aspirin got downgraded in the primary prevention guidelines. We could have seen this coming but it took years and years and years. It had been recommended by every physician to their patients for secondary and primary and now recently the data shows up and shows not all benefit in primary prevention etc etc. I am not saying vascepa is similar just using that as an example of just how big I believe this to be and why it is so hard for wall street or any analyst to properly value.
Anyways, sorry about the rant, I am on a flight back to NY and just posted this and it froze so I am trying again.
Primary prevention. Well we are no where to be found in ACC primary prevention guidelines though really not shocking. http://www.onlinejacc.org/content/accj/early/2019/03/07/j.jacc.2019.03.010.full.pdf?_ga=2.95451548.1055637493.1552696733-435281320.1552696733
Vu and raf. Agree with you both in that AHA>>ACC conf. This will still move the stock Esp with snda submission looming. There’s def a lot more data to be presented from Reduce it so you expect good but hope for great with this conf.
That would be amazing bc to me the ITC case is an overhang.
Doubt it. Hope I’m wrong. I just don’t see it.
Next leg up has to be with making guidelines. A European partner. Winning ITC. more buy out spec. Or getting priority review for the snda.
None of those abstracts to be presented will be practice changing after reduce it results. This is just additive literature even total ischemic events. Also, I like Jl am waiting for Epa/Aa info. That can be practice changing and should be released ASAP.
The only problem with EPA/Aa ratio proving our concept and demonstrating who is to benefit is copy cats will have a new biomarker to chance after. Thankfully we have a head start.
Nice to have your input. I’m expecting as fast as possible on this guideline given its magnitude and now two studies Jelis and Reduce it With reduce it being the best quality evidence you can have.
Agreed. Weak news. We should be in guidelines as a stand alone. disappointing thus far. Will take more time.
Hm. That’s a fairly disappointing way to end my night shift ha. Thanks.
Monday March 4 8 am embargo lifted on ACC abstracts.
I see a post on twitter and looked at the PowerPoint and consensus statement. I think good find but we need more. It Does state and mention keep TG<150 and mentions reduce it and Jelis but not the standard of care guideline statement claimed unless I don’t see it.
We really need AHA guidelines.
Where’s this rumor? Any article out that I can’t find. Thx
Thanks for doing this
Amrn almost definitely gets bought out. Qs is when.
95% / 100 PPS / Dec 2019.