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CBB. No EU pharma co is buying AMRN without a realistic plan to get reimbursement in Germany , France and Italy.
So far AMRN has failed to detail such a plan .
Maybe they will at the May earnings report.
NVS is the most obvious EU Pharma ...especially now that the EU patent life has been extended .
So can Sarissa buy more shares before the buyback ? Doesn't this have to be approved by UK ? regulators first and therefore wouldn't they have inside knowledge of those proceedings ???
Kiwi
The benefits of diversification
I have positions in UNCY , RZLT ( sold half recently up 100% ) and TLPH ...plus a little AMRN cos I'm an idiot and take their drug Vascepa
So the gain in TLPH today outweighs the loss in RZLT and UNCY .
Now if I could just get all 3 heading higher ...:--)
Kiwi
Well they may have finally got their pivotal trial underway ( was delayed due to hospital site admin delays ) ...stock up on heavy vol
Kiwi
Unfortunately this has turned into one ugly chart for a Co about to release results of an Open Label trial .
I still hold a small position ...ala bet only what you're ok with losing .....but not as gung - ho as I once was.
Kiwi
Well Capt I'll be interested to see what mgt says during the earning release CC on their plans to gain reimbursement in Germany , France and Italy .
Hopefully they will provide details and a time table .
Thx for your charts etc . They clearly demonstrate the risk reduction especially in certain sub groups .
When you look at the cost of revascularisation following a PCI .....The savings to health depts would be substantial even if you reduced RR by only 25% ( to allow for possible overstatement of benefit due to placebo used in R-IT)
Well since you have an email relationship with Denner ...ask him why Germany is not onboard .
Kiwi
RMB. This is what Germany wants
Ram. I agree that we are very unlikely to see another EPA trial the size and length of R-IT .
A trial of a high risk sub group ...say 2,000 PCI patients followed for 3 yrs for rate of re vascularization ? What's the patent life in the EU now with the new extension ?
If thats what it takes to get reimbursement in Germany and France it might be worth it . At least more / larger RWE studies.
Well the quick answer is that those EU health depts that wasted tax euros reimbursing a drug with no CV benefit ( Omacor /Lovaza ) came under a lot of criticism .
So many now want independent confirming data
Kiwi
Ram Why do I have problem with the buyback . Short term its a win , long term a waste of $
So my plan is to accumulate under $1 ...if the buyback pushes the PPS over $1.50 ...I"ll sell ( 50% return ) unless I see them making concrete plans to increase the level of evidence that Germany and France will likely want before reimbursing.
Why risk a trial ( even a small one in a select subgroup ) and risk a different result ...because without that independent trial many in the Cardiology community remain unconvinced.
There were at least 13 independent trials confirming risk reduction of Statins
At least 3 for PCSK9's ...
Germany has always wanted independent placebo controlled trials before reimbursing CV drugs ...at least in recent years . If you aware of a CV drug reimbursed in Germany based on 1 double blinded trial , please post it
Kiwi
RMB. I think it was this trial. The results of the
So here's an example of what these AMRN guys / girls are getting
RE your view
Re
Nope. High TG's with high LDL was a known risk factor . Lovaza was the go to, to lower high TG's . Problem was it raised LDL levels significantly for some.
HeFH patients such as myself often also have mixed D ( High TG with low HDL ) . I couldn't take Lovaza because my LDL was still around 180mg/dl in max dose Lipitor .
My TG's in the low 200's .
So ...back in the day of the Anchor SPA ...we were waiting for AMR 101 ( now Vascepa ) to be approved for reducing high TG's without raising LDL cholesterol .
I think it was a Co called Reliant that developed Lovaza and sold it to GSK ....this is before we found Lovaza did not reduce CV events .
So if the Anchor indication had been approved ...AMRN would have existed as an alternative for those that couldn't take Lovaza.
Omacor ( Lovaza in the EU ) was big business in many EU countries , especially Spain that reimbursed generously for it .
Kiwi
I posted this on biotech values board last week
We are up 189% over the last 3 mths . To reduce exposure after this run is simply good risk management .
A large enough sell order to reduce exposure ,can trigger a cascade of stop loss orders .
Market will be looking at near term P2 DME data as next major catalyst .
JMO
Kiwi
LS. as a follow up . Renvela is also swallowed but most require 2 pills ( fairly large ) with each meal.
OLC ( Lanthanum ) is far more effective at lowering serum pho
https://unicycive.com/wp-content/uploads/2023/05/Renazorb-Phosphate-Binders-Daily-Medication-Volume-Poster.pdf
Kiwi
LS. good question
My wife prescribes a lot of Sevelamer (Renvela® or Renagel®) largely because its what the issuers will cover . Her patients hate the drug and most are nowhere near serum pho goal .
Those who absolutely refuse Sevelamer , she will go thru the prior authorization hurdles for them to get Fosrenol ( which I believe costs more ) .
If a brand pho binder that patients will take ...1 small pill with meals , swallowed , is approved and the copay is affordable , the thinking is that more Nephrologists and patients will push for it.
The current SOC re pho binders is a failure . 85% of the roughly 400,000 US dialysis patients on these SOC binders are nowhere near pho goal because of pill burden and taste .
Note ...the existing Fosrenol generic is CHEWED ( or in powder form ) Patients hate the taste. The OLC bio equivalent is SWALLOWED .
I don't have a clear idea on pricing , rebates etc except they need to make the copay affordable ...something ARDX did not do with their Xphazoh.
But first they need their final " tolerability " trial to succeed.
Kiwi
Ram. interesting pt of view .
Mine is summed up as follows
UNCY ...my pitch
First this is a risk only what you can afford to lose spec. Trial failure ...to many dropping OLC due to side effects especially nausea and PPS will be at least cut in half ...JMO
Upside potential ...for what it's worth
Disagree re reminiscent of Statins .
I've been on them all since late 1986 ( the first Mevacor was approved in 1987 )
In 1986 I was a " Lab rat " at UCSF ...denied health insurance due to family history of heart attacks .
UCSF provided some coverage provided I'd be in their CV trials ...was on the first statin for about 6 mths as part of a safety study before approval .
Back then AST /ALT Liver tests very mth .
Biggest change was the introduction of Lipitor. ....first high intensity Statin
Kiwi
Todays action is what I'm looking for ahead of trial results .
Upside swing on increased vol .
I added back some this AM
From Piper earlier in the mth
RMB. OLC is the bioequivlent of Fosrenol ( Lanthanum Carbonate ). . My wife has a few patients on Fosrenol .
The history with Lanthanum is roughly as follows ...from a large trial in China
RMB. I was referring to the volume around the presentation on the 18Th
There was a large block purchase at the time of that presentation and then slow steady selling into the close on Friday .
I would have preferred constant buying into weeks close . It may have been just " risk off " due to over all market sell off.
One key thing from the presentation was the Ceo saying trial results in next few weeks . I read few weeks as 2-3 weeks where as originally I thought results not until after mid May ie 4-6 wks away.
I still hold a core position . May add more if market melts down next week .
The biotech spec funds I follow ... Vivo Capital , Nanathala , RA all have large positions in the Co and have not reduced them as far as I can tell.
I lean to wards the trial succeeding with patients accepting some minor AE's for the trade off of lower pill burden ....but it's really how much do I want to risk as failure will trash the stock
So there may be 3 X to the upside on good trial results and 80% to down side on trial failure .
For me it's how much of a loss I'm OK with if trial fails .......such is life investing in clinical trial outcomes
Kiwi
https://www.channelchek.com/videos/unicycive-therapeutics-uncy-noble-capital-markets-virtual-healthcare-conference-replay
says trial data in " next few weeks "
Kiwi
Thx Laurent
Re your view
Always ...I'm long AMRN with average purchase price of around $1
I also take Vascepa
Why am I long AMRN ? In the hope that Sarissa et al will eventually get their act together ( besides cost cutting and cash flow management ) and generate some data that will convince Germany and France to reimburse for Vazkepa .
More Real World data such as we recently saw from the VA is what I want to see. Larger studies with P values .
Look at some of the sub groups listed by poster Capt.
Revascularisation rates for those on a Statin plus V vs Statin alone were dramatically lower for those on Statin plus V . Kaiser and the VA must have a ton of data on this by now.
The buy back is a dumb idea IMHO ...simply to make disgruntled share holders feel better .
I expect both Zip and I will either be 6 ft under ( or ash's in the wind ) before AMRN makes any significant $ out of China
So cheer up Always ...you aren't the only one currently losing $ on their AMRN position
Kiwi
Well not everyone can put out a SA article ...ask Dr Ralphey
Several years ago he wrote a long hard to digest article extolling the virtues of AMRN ...that SA declined to publish :--)
Kiwi
Ahhh Thx . I had pitched UNCY some time ago . Reduced my position today as stock sold off on almost 3 X normal vol , after a presentation .
Not something I like to see .
Will hold remainder thru to data readout in June.
Kiwi
RMB. Well they had their presentation but now stock is heading lower on almost triple vol ...so I reduced my position .
Will hold some thru readout but todays action is not what I want to see following presentations
JMO
Kiwi
RZLT. ..follow up to my Feb 20th pitch
My guess is that they have completed the P 2 DME trial and will publish results in May 2024 .
I'm up over 100% on this position so have sold half (. Ala bulls make $ but pigs get slaughtered ...or something to that effect )
Will hold the remaining 50% thru read out .
Kiwi
Dew. thx for the update re Parkinson's
Kiwi
Re
Another huge vol day to the upside ( at least so far today ) , so congrats on accumulating .
The p2 DME trial has ended about now ...so its now down to data checking and publishing the data .
I have no idea if the recent increase in PPS is a data leak , accumulation for a buy out or simply due to speculative positioning .
Guess we will know in " the fullness of time "
Kiwi
Wedbush Reiterates Outperform on Edgewise Therapeutics, Maintains $26 Price Target
I'm surprised stock didn't do better on recent P 2 data ...which was supposed to " de risk " their program
Kiwi
EWTX. well here's the 24 mth open label data to hopefully derisk their program
https://ih.advfn.com/stock-market/NASDAQ/edgewise-therapeutics-EWTX/stock-news/93659509/edgewise-therapeutics-announces-positive-two-year
Kiwi
FWIW
Benchmark Reiterates Speculative Buy on Unicycive Therapeutics, Maintains $3 Price Target