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FFS. re this post
RMB. I think we are due for data from the LYNX trial
Prior Art on EPA for Migraine Relief
Congrats on your Gr8 find / hold
Kiwi
They don't have any patent protection for use in treating migraines ( no method of action or composition of matter patents ) ...so I'm sure the generics and supplement Co's would love AMRN to waste time and $ on such a study .
Kiwi
Thx Dew. Do U use Perplexity at all ?
A quick search on the difference between Eyepoint and Ocular
Chromosome And I completely agree with your analysis , assuming they mine the data Kaiser etc are accumulating .
Make the economic argument in the EU for the reasons you mentioned.
The RR in select subgroups such as Revasc doesn't have to be as high as R-IT in the RWE study ...it just needs to be clinically relevant and a cost effective use of the Health Dept funds. ...( ie The Health Dept will save Euros by reimbursing for the sub group studied )
Kiwi
So what would constitute a stronger dossier ...Real World Evidence studies that the previous mgt once floated ?
As you probably know ..Real World evidence studies rarely show the same degree of RR as the original trials.
This is well known and the reason is that in most CV trials the patients that enroll are often more health conscious than the general public and are more likely to adhere to the dosing schedule.
So knowing this you focus on that subgroup with the highest RR thats quantifiable and can easily translate into healthcare cost savings .
Even if the Revasc subgroup only showed a 20% RR vs the over 40% reported in R-IT ...its still a huge saving in healthcare cost .
Ask posters here who have had a PCI what they cost ?
My angiogram / angioplasty in 2016 was $18,000 ...no over night stay and no stents
This didn't include the ER costs ...just the Cath Lab costs
One of my business partners had several stents , in hospital for 2-3 days I think ...close to $100,000
Kiwi
Capt. The issue is how to obtain reimbursement in the remaining big 3 EU markets and spark an increase in script numbers in the existing EU / UK markets .
The current strategy ...same ol same ol ...isnt doing it ( Spain being the possible exception ...but still only 2,000 scripts IIRC )
So what's the boards ( and your ) suggestions for gaining reimbursements and increasing script number in these markets ?
Kiwi
Well your mindsets seem to be to stick with the same ol same ol ...cos eventually ....eventually , the entire Cardiology community will see the light and start aggressively writing scripts ..especially in the EU
Meanwhile ...do the math here, Q1 24 over Q1 23 saw a 41% decrease in US revenues . Similar will happen in Q2 and Q3 and Q4 because the major health providers like Kaiser have switched to generic V or are forcing AMRN to beat generic pricing to retain their market share .
Great deal ..hey we have retained our US market share ...but were losing $ doing it ..but never mind
And while this is going on in the US ...script growth ( except in Spain ) is barely moving .
But lets stick with the same ol same ol ...with a $50m share buy back thrown in so mgt options that vest next April, can maybe cash in .
Cos thats the best idea we ( mgt ) can come up with .
Kiwi
https://eas-congress.com/2024/. Big Cardiology conference in the EU coming up
What's AMRN presenting ...anyone ?
Alright
Chromosome ..Well I am definitely in the minority .
You may think R-IT is the gold standard but because of the placebo used some major figures in the Cardiology world don't buy it .
Capt has a long list of non believers .
This affects script uptake here and in the EU
The current trajectory for AMRN ....significant decline in US sales , combined with minimal sales in the EU indicates a slow steady decline to oblivion ...not a BP buyout.
So what to do about that ?
Apparently nothing according to most on this board
Kiwi
Jim I was on Mevacor . Back then it was only for the HeFH indication I believe. Approval for primary prevention etc for CAD came years later ...1995 I think .
Above is just from memory .
The big change was Lipitor . I was given free samples that lasted about 6 mths ...handed out like candy on Halloween, when that hit the market .
Did you sell Lipitor ( Atorvasatatin ) also .?
Kiwi
Cosa ...No I had sold all my shares in the $4's thinking there was upside to UNCY ...we''l know if that was a good idea or not probably by the end of this month.
They say roughly half their sale are to Medicare patients ,
But Medicare can't use the coupon so its a Tier 5 drug ( at Kaiser anyway ) where patients typically pay 1/3 rd of the cost ...in this case around $1,000 each month
Co won't disclose how much of their " sales " were no cost to the patient .
Scripts are normally 30 days at a time ( NDS ) with a PA ( prior approval ).
Most hate the existing Pho binders so getting the PA is no problem . Getting renewal month after month at no cost to the patients ...dont know how long that would last or how many of the Medicare patients actually paid the full copay .
ARDX had prepared the launch really well . Had Renal depts identify those most likely to try XPHOZAH all ready in advance and then I suspect dropped a whole lot of free samples for the first month or 3 .
IF the copay for Medicare patients is around $1,000 a month , few of these patients IMHO will stay on X ...or sharply reduce how much they take each day
JMO
Kiwi
Another example of a short CAD trial ...this time in Sweden
Try this with available Kaiser data
RMB. As I have posted before . You pick a R-IT subgroup with a high risk reduction where the event lines separated fairly early . The Revasc rates ...especially second revasc rates as an example.
Real life example .
Wife was unable to dialyze one of her patients recently because he was complaining of chest pains . Sent to the ER where they found one of his coronary stents had re occluded ( plaque had reformed possibly as a result of injury to the vessel sustained at time of PCI ) .
Patient was not on Vascepa
So run a short trial ...or at least look at Real World evidence for these patients ....Kaiser must have lots of it by now.
SOC ( standard of care ) vs SOC plus Vascepa ...follow rates of re occlusion following a recent PCI .
Huge cost savings if re occlusion rates fall for those on Vascepa .
No placebo , open to all TG levels
Kiwi
Snd. RWE studies are done all the time to inform regulators and physicians ...I've easily identified several .
Heres one on PCSK9's in Germany
Here are some examples of real-world evidence studies on existing cardiovascular drugs:
N7. Dr Nissen has made this a scientific / medical debate . Real World Evidence follow up studies are done all the time ...including studies done by the German Health Dept . I linked a follow up real world data study they did on 2 blood thinners recently ...a short 1 yr study .
Regarding math resolving in our favor .
Here's a math challenge for U
Q1 2024 shows a 41% DECREASE in US sales vs Q1 2023 . Meanwhile sales growth in the UK / EU is minimal .
This company is shrinking right in front of us with the current game plan
Kiwi
Well no thats not how it all works now . Sales reps are prohibited from visiting my wife's Renal Dept ...and yes she does miss those free lunches with young male CQ model type sales rep pitching her some drug .
And I miss the all expenses paid trip to some resort ( I got to tag along ...room was paid for ) ...but sigh ..those are the sacrifices we must make .
Kiwi
Don't underestimate the shade Dr Nissen has spread ...it reaches far and wide .
Kiwi
Ha Ha ...oh jaded one
Kiwi
RMB. Conferences / symposiums are big for launching new drugs in the EU / UK
Usually attended by heads of depts or the top team and then if convinced , issue a directive once back at the hospital .
In the US this happens also ...related to my response to poster Chromosome ... Valtessa was approved but not being used for lowering serum K at my wife's Renal Dept.
I asked her why not . Her answer ...Boss hasn't approved yet .
Boss goes to a Kidney disease conference ..does a deep dive with the Valtessa team ...comes back and says OK start using Valtessa .
It was like a light being switched on.
The conferences / symposiums aren't driving Vazkepa uptake in the UK , Netherlands , Sweden and AMRN mgt needs to explain why that is
JMO
Kiwi
Re
My comments on the ARDX board relevant to UNCY
Cosa. These are excellent first Qt numbers for XPHOZAH but keep in mind
1) They aren't revealing how many are getting the drug for free ( via their coupon plan ) . They simply say around 55% are Medicare ( who can't use the coupon )
So are those on Medicare paying the full patient copay of an estimated $1,000 a mth ( Tier 5 rating )
They have probably provided a lot of free samples for the first couple of months ( my guess )
2) Early adopters . One of the main complaints on the existing binders is constipation .
One of the main problems with XPHOZAH is diarrhea in the first 2 wks ...less over time.
So the Nephrologists will have identified this who complain of constipation the most and offered them X ...as they want a " looser " stool anyway.
3) We have the final UNCY trial with their binder completed ...data due probably late this month .
This is 1 small pill with each meal vs 1 small pill at breakfast and 1 with dinner . Diarrhea is less of a problem with OLC but some experience nausea , stomach upsets. UNCY's final trial is about tolerability not efficacy .
If UNCY's trial fails ARDX's XPHOZAH will be the only new serum pho lowering drug available.
If UNCY's trial succeeds X will have competition in about a yr
Kiwi
Cosa. These are excellent first Qt numbers for XPHOZAH ....sorry ..post repeated .
Either way shows how patients hate the current binders and Nephrologists are excited to offer an alternative that reduces pill burden and gives them dosing flexibility
ARDX now has first mover advantage even if UNCY's drug OLC eventually makes it onto the market
Kiwi
Cosa. These are excellent first Qt numbers for XPHOZAH but keep in mind
1) They aren't reviewing how many are getting the drug for free ( via their coupon plan ) . They simply say around 55% are Medicare ( who can't use the coupon )
So are those on Medicare paying the full patient copay of an estimated $1,000 a mth ( Tier 5 rating )
They have probably provided a lot of free samples for the first couple of months ( my guess )
2) Early adopters . One of the main complaints on the existing binders is constipation .
One of the main problems with XPHOZAH is diarrhea in the first 2 wks ...less over time.
So the Nephrologists will have identified this who complain of constipation the most and offered them X ...as they want a " looser " stool anyway.
3) We have the final UNCY trial with their binder completed ...data due probably late this month .
This is 1 small pill with each meal vs 1 small pill at breakfast and 1 with dinner . Diarrhea is less of a problem with OLC but some experience nausea , stomach upsets. UNCY's final trial is about tolerability not efficacy .
If UNCY's trial fails ARDX's XPHOZAH will be the only new serum pho lowering drug available.
If UNCY's trial succeeds X will have competition in about a yr
Kiwi
RMB. chk my post on the ARDX board .
The fact that 60% of those trying XPHOZAH are Medicare patients and therefore can't use the coupon ...must pay the roughly $1,000 a mth copay ...shows you how much these patients hate the current Pho binders
Obviously a strong market demand .
We need the final UNCY trial to succeed ( low drop out rate due to tolerability )...data due late this mth hopefully
Re XPHOZAH ..they will start those complaining of constipation on this drug first ...due to 45% experiencing diarrhea
Kiwi
30 min in on the call ...60% are Medicare patients ( XPHOZAH )
Impressive ...just shows how much they hate the current binders that they are willing to fork over close to $1,000 each month as a co pay ( since they don't qualify for the coupons )
Watch the UNCY data due late this mth ,,,,an obvious direct competitor in a year if their trial succeeds.
Kiwi
Thx. I'll listen to the CC ( or read the transcript.)
Most of my wife's dialysis patients are on serum pho binders ...they all hate them and none are at goal .
Most are Medicaid / Medicare and none are trying XPHOZAH at present
My wife also has some patients on Fosrenol ...a new version of which OLC ( UNCY ) will report pivotal data late this mth
1 small pill with meals vs 1 small pill with breakfast and dinner for XPHOZAH
Kiwi
N7. I'm assuming Denner is acting in his best interests which hopefully align with ours ...altho Tats posts ( re Denner short selling ) has made me question that .
On balance I think we want the same thing ...a higher PPS for AMRN
Re Jasbg posts ....I basically ignore them which is unfortunate . He posted some great Playing for Change music clips ( one filmed near where I live ..and featuring someone I'd met as a neighbor ) ) which I enjoy.
Music may bring us together when all else fails .....hopefully not wishful thinking .
Hope AMRN works out for you
The current period reminds me of 2014
Then PPS was under $1 and AMRN committed to finishing the R-IT trial ...which main stream Cardiology expected to fail.
We need the same " we'll prove it " in the EU . A short trial or study that will convince the remaining big 3 EU markets the Vazkepa will reduce events and save them Health Care Euros.
We're against the ropes ..just as in 2014
We need bold moves and we have some time due to the EU patents extending out to 2039
JMO
Kiwi
N7. as you know ...there is no way AMRN fails to exist with $300m cash on hand near term ...even if they were losing the same amount of $ they were with prior mgt.
Many of us may have our reservations about Denner ...but at least he has stopped stupid waste of the Co's resources .
Kiwi
Well before U get to excited about XPHOZAH ...those on Medicare / Medicaid are excluded from their coupon plan ( no cost to private insurance patients )...and most on dialysis are over 65 ( the Medicare / Medicaid population )
So good impression out of the gate for the low hanging fruit
JMO
Kiwi
RMB. I actually think the XPHOZAH results for ARDX today are a positive for UNCY ( assuming their pivotal trial is a success ) .
Their results demonstrate the need for a lower pill count to effectively address high serum Pho
UNCY can presumable underpriced price ARDX ..offer a lower price for a small 1 pill with every meal vs 1 small pill with breakfast and dinner .
XPHOZAH sales are driven right now by their coupon plan ...Co gives the drug for free to those on private insurance . Medicare / Medicaid aren't eligible which is why none of my wife's patients are trying it .
Most on dialysis needing a better drug to lower serum pho are over 65 ...Medicare / Medicaid
Kiwi