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My read is a little nuanced. Not so much about current IP protection, more to do with:
- a 2nd generation product protecting/extending franchise if R-IT positive;
And indirectly also locking up or blocking EPA supply to competitors whether that is prescription grade followers or DS.
Its a good point and wondered if anyone had any views on it.... AMRN is always covered by 2nd tier brokers, no major firms or healthcare specific brokers.Have always been curious why this is so!
oh and the glass doctors room doors stand out too! :)
talk about privacy hehe
Ok great thanks HDG.
Question for anyone reading... if you look at Anchor the trial was only over 12 weeks and now in R-IT obviously much longer over a number of years. I was curious if the mentioned side effects of bleeding by Dr Budoff could happen more over a longer period? I know there have been 3 month safety interval checks by the DMC , does that mean this safety risk accrued over a longer period is fully mitigated or not known at this point?
also can someone remind me what the baseline TG is in R-IT as compared to Anchor.
thanks in advance
Hi HDG
Were you expecting BB to convert into common stock? why is this point relevant? either way not sure how you view that as something material eithr way?
thanks
PS enjoy all your contributions on here, even if sometimes they are hard to comprehend :)
cant see the problem with the wording there BB and not sure why you are incredulous, its pretty clear what they are saying.
Thanks for your reply, I think your analysis is for sure worthwhile... in fact for me numbers are close to irrelevant even while the core biz is growing OK, as you know its all about potential 'shareholder value' post R-IT, not really 'underlying profit' even. There is NO investor/shareholder that is looking for AMRN to show sustainable profit, especially now. Maybe if R-IT fails (as you are so convinced it will) the remaining investors will start focusing on what 'profit' remains selling V in its current indication...
However lets be rational, if R-IT comes good, there is no doubt about the size, market etc that won't dictate 'shareholder value' be that M&A or increased sales growth.
I think your posts are worthwhile, maybe more so than all the posters on here talking about secrets and what not and who are myopically optimistic about everything Vascepa... however be that as it may - its clear you are a "glass half empty" guy in general and I guess that could be the right way to think from your experience in smallcap bioland. I don't think AMRN management/company is really any worse than most out there and in fact after listening to the call now go, they even go out of the way to be responsive and transparent, more than I can say for many other companies. In fact I think its an achievement for a small company to get this far and I am hoping for shareholders and patients R-IT is successful.
PS- what level did you commence your short?
Good analysis thanks, I agree in general but two things to note:
1. KOWA co-promotion ends post R-IT results in a few months along with all the R&D expenses
2. AMRN is not unique here, this is the name of the game in bioland. even in large cap bioland. Look at VRTX perhaps one of the best of the best $44bn company, basically monopolises the whole of CF and still struggling to show real sustainable growing profits!
One thing I agree with you is on the stock comp, head I win, tails I also win. But that being said on the numbers, have to give them benefit of the doubt, 'AMRN is a small company doing big things' as JT says, hence also the constant dilution.
This WIDOW MAKER was a great documentary thanks very much for posting!
Interesting to see Dr Budoff and Dr Nissen take different views on preventative scans, and now facing off again with REDUCE-IT.
Documentary doesn't imply one party is right or wrong. What surprises me is that even if Nissen is reportedly negative on REDUCE-IT because of mineral oil VS corn oil, he is obviously still very interested in the science AT THE RIGHT DOSE doing the same trial for Epanova (and AstraZeneca)!
this has to be the most confounding stock.. all the data says AMRN has an OK chance of succeeding in REDUCE-IT (I mean the doc said 85% chance!) and if they do, the market is truly significant as there is clearly an unmet need...
however if you believe in a totally efficient market, the pre-readout capital raising (questionable?) and poor stock price performance is implying odds are very very low.
confounding to say the least...
thanks Kiwi, always enjoy your valuable contributions on here as a patient and as an investor.
The doc obviously disclosed upfront his relationship with AMRN and of course there can be a conflict but at the end of the day, he obviously believes in the science and the key differentiators:
- pure EPA (banged on about this and that all other trials are combos)
- the dosage (banged on about non being 4g mentioned even JELIS only 1.8g)
- the right patient population enrolled (high trigs, diabetics, all the subgroups and SE's)
for me I have no clue where the RRR comes out... I hope double digits, but no point speculating because nobody really knows. If you take the doc's word that there will be significant adoption if hits as you know nothing else out there to reduce risk.. and how optimistic he is on success, I think presents a good opportunity. That's why I increased my holding. That being said, I also understand Phyr's view that you could wait for the results and buy then as its safer and you take out the binary risk and there will still be significant upside if it hits (albeit a bit less).
don't think you could ask for a more positive call and opinion from this doc. I am taking him at his word.
basically stated adoption would be nothing short of massive if hits.
and also that they enrolled the right patients and that the dosage of 4g of pure EPA is the key differentiator.
Only disconfirming evidence is the share price with significant volume which I am putting down to simply nervous pre-trial binary action, people who traded this for the run-up exiting, stop losses, consonance selling down, limited understanding that its not fish oil and that reduce-it is not related to ASCEND or VITAL.
I just increased my position by 50%.
crossing fingers this doc is right.
PS. Kiwi keeps on banging on about this trial not being designed well because LDL levels are already low. I think he is missing the point totally. LDL needs to be low and controlled in the trial in order to assess the benefit of EPA alone, its lowering of trigs independently of LDL and the associated read through to outcomes data.
Most probably the best article on V’s chances I have ever read...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4911828/#!po=26.5152
Any thoughts or anyone seen this publication?
obviously!!
I agree would be amazing for AMRN if EPA is proven to work but even with a takeover control premium, not sure if 10bn is very realistic. hope I am wrong though.
raf,
yes but playing devils advocate... perhaps th 8% mentioned could mean that after the IA, management massaged the expectation lower than 15%...
I concur with your A and B but to be honest your C while I would be ecstatic about RRR of 33%, even then it just seems a bit unrealistic, a circa $10bn market cap in 4 months. odds very low imo, not realistic. Although I do agree with you if markedly positive, many buyers will likely come into the name after the trial, not now. My 2c
I love the scientific literature. On balance, that's the only reason I am here. Not only JELIS but sub-groups of AIM-HIGH and ACCORD. As well as the post PCI (Nosaka) and also CANTOS etc regarding inflammation. But funnily enough I never see any reference to the HPS2-THRIVE study where the subgroup analysis was NOT supportive!
Only issue I have is that Outcomes trial data is still one big unknown unknown, there is no way to know until we see the data.. and also how this fits within the context of PCSK9's. Even then.... why have there continued to be questions around the mineral oil placebo influencing statins, a subject the FDA surely must have addressed in the SPA that allowed them to continue with trial?
I am not so sure I am able to speculate on the numbers as honestly I have no idea... a bit different to most on here!
what I am trying to assess though is if EPA is deemed not to work or in general 'fails' what happens to the existing business?
This was always my investment thesis that they have an underlying business there which is growing in smaller patient population, but still reliant on Kowa. how would you value this part of the biz if trail is deemed a failure? i.e. what level of current/future sales for MD or SHTG will remain or disappear?
Always good to see rising scripts. Thanks for posting.
Ignoring the disappointing share price... most probably everyone expecting a run up to lighten up risk... so the exact opposite happening! Hopefully same thing will happen where market price in general is implying a bad result... hopefully the exact opposite will happen there too.
One thing I am curious about which maybe someone can add which I think was mentioned on the last cc is what happens if trial misses and only hits a few SE's - what will then happen to the core biz which has been growing strongly over the past few years?
Would the growth stall, slow or would the KOWA agreement and trial cost ending mean shareholders would finally see some FCF?
hard to know this but lets assume trial doesn't work, there would still be a business there right?
WORKING LINK...
https://www.medscape.org/viewarticle/896755
Can anyone can get access to this:
https://www.medscape.org/viewarticle/896755?src=mkmcmr_driv_stan_mscpedu
discussing PCSK9's with Dr Bhatt in there too.... Is V mentioned?
I know we all talk about V but not much is mentioned about PCSK9's whose list price has come down (not to V levels but still down a lot) and whose RRR so far is fairly meaningful (more than V?) barring the extra side effects... even the board's favourite person Kiwi is starting to take them :)
what RRR% is considered meaningful in comparison to PCSK9's in context of its better tolerability?
this is something i am struggling to come to terms with. I guess we will all know very soon....
Hi Bio
Thanks for your post (and all the previous ones) and response to my question on the mineral oil placebo. I did some digging and found this class action here:
http://securities.stanford.edu/filings-documents/1051/AMRN00_01/2014919_r01c_13CV06663.pdf
Knowing your thoughts on what happened, I am sure you have seen it.. but
On page 24 it talks about what happened with the mineral oil placebo in relation to ANCHOR but also mentions that it wasn't changed for REDUCE-IT after FDA SPA review. I was curious do you see this as moot point now as we are so far advanced with REDUCE-IT or do you think the rumoured comments from Dr Nissen are relevant in the context of this document or are more just a case of sour grapes?
Its no wonder you get attacked. I would advise if you don't want to be accused in future... you should try and play the ball and not the man.I am not looking to spread 'baseless' rumours either, why would I bother posting and asking the question here? Do you think I made it up?
And no.. I disagree, its not even close to your ridiculous paedophilia metaphor. No-one would do that. Dr Nissen's comments on the REDUCE-IT placebo as the key investigator and sponsor of the STRENGTH trial (link below) is likely relevant whether his comments are baseless or not is why I asked the question.
https://clinicaltrials.gov/ct2/show/NCT02104817
don't have it and couldn't find it online, it was through the grapevine from an AstraZenca analyst day with him talking about the V placebo being mineral oil which I thought was already accepted by the FDA during the SPA... hence why I thought someone on here would know about...
Hi All
Really enjoyed some of the comments on here.... Some really good knowledge out there from some very long term users of V, statisticians, physicians, believers in EPA and also believers in REDUCE-IT. Please keep up the great thoughts!
With regard to the stock, sentiment over the past few months seems to be hit by not only the meta-analysis saying 'fish oils' don't work... as well as the fact that their chief legal officer sold his stock in advance of another dilutive capital raising.
The one thing I was curious about was the comments from Dr Nissen (the chief study investigator) from Cleveland Clinic for AstraZeneca (Epanova)going out of his way a few months ago saying he thinks REDUCE-IT should be invalidated due to the placebo being mineral oil instead of corn oil or something of that nature. I did some research online and saw there were some concerns from the FDA debacle about the use of mineral oil as the placebo.. Dr Nissen was saying it cant be effects of V, it has to be because of the Placebo that the results are so good. I am not sure how to take that comment or how much truth there is to that or if this is someone who has an axe to grind cause of AstraZeneca. Maybe some others on this board also knew about this and have any further thoughts around this?