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Haven’t posted in awhile but still “obviousness” kills me. Can anyone explain how all the statins after the first were not “obvious.” This has always been a big qs of mine after Generics prove vascepa was obvious.
Statins all target the same mechanism of action of hmg co a reductase inhibitors. How, after the first, were these others able to produce more brands. I don’t get it.
“Since lovastatin had been commercialized, 6 statins, including 2 semi-synthetic statins (simvastatin and pravastatin) and 4 synthetic statins (fluvastatin, atorvastatin, rosuvastatin and pitavastatin) have been introduced to the market55,79”
Since lovastatin had been commercialized, 6 statins, including 2 semi-synthetic statins (simvastatin and pravastatin) and 4 synthetic statins (fluvastatin, atorvastatin, rosuvastatin and pitavastatin) have been introduced to the market55,79
I don’t get why they made this a late breaker and also why KM hyped this Last week.
Maybe. I thought the use of the word “shock” was odd and may elude to a diff type of trial. Typically covid pts are not in shock on pressors etc.
“This treatment was offered to her following our success with this regimen in patients with inflammatory response and shock (report under review for publication). “
is there another IPE trial we we weren’t aware of that’s about to be published ?
You’re right but he’s sAying the pro inflammatory effects outweigh its positive effects on cholesterol.
All I can say is this continues to build a very strong evidence for skepticism which gives us points on our future reduce it patent fights in the USA. Take it as a positive.
What does Nissen want ? He needs to be investigated. Weren’t we supposed to get a list of his emails with Janet/FDA? Did that never happen. His motives IMO are corrupt.
Yeah. Only 1. Really frustrating. Nevertheless, I didn’t think prepare it 1 could hit stat significance but the way this is coming together and being presented as a late breaker and in Amrn PR it seems to be a positive trial.
Nice post. Thanks for your insight. Much appreciated. This is a tough wait which is weird when we have waited in this stock for years and years with nothing to show for lol Covid therapy can bail us out and get this ship moving again.
To confirm, you think P1 and P2 will be presented? This has been a little unclear to me but I trust your DD. I REALLY want this data particularly P2 but am concerned it’s going to be hard to show a benefit depending on the number of Pts who got a vaccine, which will introduce an annoying confounder.
Everyone knew this decision. No surprise after orals.
1B opportunity not including Europe not including USA. That’s more bullish than JT has ever been. best thing I’ve heard so far guys.
That sucks. I was hoping to see #2.
Masks don’t work to protect yourself. Obviously you can debate but here’s no reliable evidence to suggest they work to protect yourself (all except an N95). They may work as source control -aka if I have covid and wear a mask I MAY reduce the likelihood of spreading it to you. Likewise a surgeon wears a mask not to protect himself but to deceased the likelihood of spreading something to a patient.
2 very diff circumstances with masks that has to be clarified bc there’s so much confusion on masks.
IL 6 inhibitors given to COVID patients inpatient like Actemra didn’t work. This was given out late and not early however. All I can say is if vascepa is given early their may and very likely will be real benefit. I wish a retrospective study was done by amrn of COVID Pts on vascepa vs a propensity score matched group of COVID Pts not on vascepa. Would have been nice to know. I shoulda done it at my institution but now it’s late and I’m sure we have results soon on the prospective front.
Can you explain how we could know our fate ? These cases were already accepted to SCOTUS and these were their final verdicts after deliberation. That’s diff than today where we are just on a calendar to even get reviewed by SC. Correct ?
Well certainly depends on baseline levels of pts that may not have been equal to start (Epa and dha levels) and then absorption and correlation of grams consumed to plasma level.
Thank you. For others. Take home point :
There may also be a required threshold of achieved EPA level (~100 µg/mL) to produce a clinical benefit. In particular, the on-treatment levels of EPA in the STRENGTH trial (89.6 µg/mL) were lower than the baseline EPA levels in the JELIS trial (97 µg/mL) and 38% lower than on-treatment levels in the REDUCE-IT trial (144 µg/mL). Eicosapentaenoic acid and DHA levels were also essentially the same in the STRENGTH trial unlike the IPE trials. As a result, there was no relationship between EPA levels and reduced clinical events in the STRENGTH trial.
Yeah I see the link with covid obviously. I just don’t see the link with posting on a vaccine side effect that’s a few hundred people out of millions. Nevertheless I see you are just trying to just show theres another potential pathway albeit possibly a small one. So thanks for clarifying. I do think covid will return in fall/winter mainly for those unvaccinated. This will be a life long virus and if Vascepa can show benefit in covid or in influenza like illness that would be great for ROW (for USA we don’t know yet until SC case). I still see severe covid infections sadly in those who refrain from getting vaccinated.
Certainly possible the dha played a part. How much we don’t know. At end of day though the theory that a certain epa blood level threshold must be reached to be cardioprotective still holds in Light of strength. Our theories exist (epa/aa or dha levels etc) but at end of day we still can’t disprove that epa blood level alone carries the weight (or most of it). The strength levels just weren’t high enough.
Why do u post such news stories on the amrn board that probably spread fear of vaccine? This just spreads more confusion. It’s a few hundred cases out of millions. Background rate acounts for some of those few hundred and for vast vast majority it’s a totally benign disease, meaning pts are totally fine.
This board should be about amrn not covid. Respectfully, Joe
I thought the epa blood levels in strength never reached the height of those in reduce it so it could still be the epa blood level that is meaningful. Higher being better. Obviously dha mattering too in strength.
Maybe they don’t know about reduce it aspect to vascepa. I just can’t imagine them not knowing about Vascepa. everyone still thinks it’s a TG lowering drug imo.
No q and A?
Nice play. I played the options on amc and it’s sad to say I’ve made way more on AMC than I have on amrn in idk probly 10 years LOL it’s sorta laughable at this point.
At least they’re addressing it. Thanks for emailing them.
Just my two sense but it may be hard to remand bc if it’s deemed legal error the SC makes the final determination and this is very much a legal error that they are arguing (incorrectly applying graham).
Hopefully SC takes the case and makes it right.
Yes. It’s conservative. However with what happened in US we aren’t going to get a bullish analyst estimate.
Agree.
any shot of covid trial read out or any catalyst before June.
Fair enough. Gluck. Hope we get some of these questions answered.
I would recommend shrinking it down and deleting questions 3 , 5 and 6 and moving question 4 upward. Also I am surprised no one other than myself wants a revenue guidance. I am open to what you and the rest of the board decide. Thanks for putting it together.
Thanks for doing this.
I’m most interested in questions 1,2,12. We need some hard numbers to create our own guidance since one won’t be provided.
Agree but I received a personal email with somewhat similar info regarding guidance so it can be real. but either way there’s nothing that crazy in that response.
Here’s part of one my recent responses
“Thank you for reaching out. Please know that I have shared your emails with our management team.
We have not provided any quantified revenue guidance for 2021. We do not think that it is feasible to provide meaningful quantified revenue guidance in a tight range due to the unpredictable timing and potential impact of COVID-19 and because pricing negotiations in Europe have just formally commenced and vary country-by-country.”
Well. They saw CVT. Portal vein thrombosis and pes dvts mostly through immune mediated thrombocytopenia. Similar mechanism to heparin induced thrombocytopenia. Should be looked into and followed but not announced over 6-7 people over millions that have received it. We probably ruined our chances at vaccinating the hesitant folks over an incidental finding or real yet extremely rare finding.
Can you comment on the timeline?
Hikma responds then we also file a reply brief 10 days thereafter?/Then court decides to discuss it at a conference. Then few days after we know if it’s accepted?
Thx. Looking fwd to it.
Wonder how vaccines effect the trial. If people went on to get vaccinated will they exclude or just do a subgroup analysis and lose power?
Ur on this board way too much to not be in this stock.
U know u wana rejoin. We have way too many upcoming catalysts the benefits risks finally weigh in our favor again.
Agree. I’m pretty frustrated. This was the only hope went Du dealt us the blow. We still had Europe. JT needs to blow this up and show investors Europe is worth a ton of money.
I just wrote to IR and
Told them I have been here since pre marine and am very frustrated.
We all want optimistic 2021 guidance. Eu approval in. Investors deserve an update and not just “it’s a billion dollar opportunity”.