Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Bfost - Not to mention that half of each dose is inert in terms of reducing inflammation. With a trial comparable to R-It, I would anticipate 15% RRR or so at best. They are selecting for TGs > 180, which helps them, but I do not see this beating or even matching V results because I am not convinced that TG reduction is the primary mechanism of V. Still, If Strength succeeds (results due October 2019), it would likely affect AMRN PPS because of perceived competition. Another reason to do BO before that is even an issue.
Funny that you can refer to an almost 10 million volume day and call it a "low volume" day. My how times have changed.
Bfost - Honestly, before 9/24, I would have been very happy with $20/sh, but my expectations have changed with the higher than I expected RRR and presumably amazing SE results. Now, I would be totally happy with $55/share, which would net us almost exactly $1 million after taxes, let us put aside a big chunk for our kids' education, and let us sell our current house and buy a really nice one in town closer to work and pretty much pay cash for the difference. Anything beyond $55 is gravy (I realize everyone is different on this though). I am leery of selling early, so we have no real "sell trigger" - we will give it to at least next summer and see if there is a BO. If not, we will re-evaluate and might sell to go ahead and be able to start enjoying the profits.
I understand all the financial arguments for GIA. What I do not hear talked about much here are the risks of GIA (even if unlikely). What if a key patent fails and generics come in quickly? What if the FDA does something weird? What if ITC rules against AMRN and "Pure EPA" OTC supplements have a huge increase in use and take a bunch of V's market? Who knows what might happen. My point in raising these remote possibilities is that the company would be likely to be balancing the value of any offer against possible unknown risks. Maybe they would like to have $75 (just an example) per share now with zero risk than wait for a possible $150 (or $35 if things go south) in 3 years. A lot can happen in that time. I think this is one reason why they might seriously entertain offers well below some of the sky high projections being thrown around, even if it means losing out on some potentially serious upside. Plus, assuming the AMRN leadership is human, they would probably like to live a little and enjoy their millions of option dollars while they are still relatively young rather than in 5 - 10 years. Just my 2 cents to stir things up.
Raf -
Close at $34.72 on November 26 (but would be happy for this to be too low)
Bfost - At some point in their pubs, they will talk about whether changes in TGs are correlated with Risk reduction. My guess is they aren't (at least not strongly). That is based on absence of this association in JELIS,.
BC - The TGs are important, not because they are necessarily why V works, but because it is a risk biomarker for identifying patients who need V. Since high TGs >150 are so common, I have no problem with this.
BB - I think someone on ST attended and said no mention of R-It today
Look at JELIS - That is not happening. UA and revascularization have the lowest RRR.
RR - Reduce-it results will lead to a label change and FDA indication for people on statins with CVD history who have TGs 150 or higher. There should be no argument. A high impact publication of results is expected around the time of the AHA conference (Nov. 10 or a little after) and I suggest you bring that article with you when you see your MD.
Rapid - You sound exactly like the kind of patient V is intended for. you should definitely bring it up with your MD.
Hope you are right
Sorry for the confusion - That was just an example - Bhatt never actually said that.
DML - It won't be. That is an artifact of the Japanese JELIS population and the weak angina definition they used (R-It includes only confirmed angina, not self-report). Even in JELIS, CV death and MI (hard MACE components) had higher RRR than angina.
Maz - I am assuming that the AHA embargo prevents them from talking about any aspect of R-It results beyond the 25% overall RRR. In that case, I don't know what they could present this week that would affect PPS beyond Bhatt saying "in theory V may help CV risk in DM, and our overall RRR results are great - please watch for more details at the AHA." This seems to be the message anyone affiliated with the company has been sticking to in public. I would be pleasantly (very) surprised if this week's conference comes out with anything new.
You are missing it - DM is listed on the tertiary/exploratory endpoint list.
JL - The R-It design paper lists new onset DM explicitly as a tertiary/exploratory endpoint. I agree that there are mechanistic reasons to think that V may affect this outcome, and clearly the company is interested in this. The only issue (pragmatic) is that R-It sample only had 1/3 people (approx 2,500) without diabetes at the start of their study participation. Depending on how many develop DM during their approx 4 year participation they may or may not have had adequate power to test this.
TTe - Agreed. I was just providing one possible explanation for the big initial drop in PPS. Agree it is meaningless.
Small % dilution Friday = small % drop in PPS today. Maybe not manipulation, but just (over)reaction.
I forgot about posting that. The number "23" had been sticking in my head since I bought the stock. Must have psychically picked up on their secret internal prediction
Raf - I would guess they might want to have the peer-reviewed publication to submit with the package to strengthen it, but that is just a guess.
BP - Nothing AMRN related. They have not even filed an sNDA yet. The company timeline said they expect it to be filed Q1 2019 in their October investor presentation.
It is confirmed that BB bought the debt - they got all the proceeds, not the company. You can google BB and corsicanto, and it pops right up.
Ex - We have a trial listed on ClinicalTrials.gov. We get a reminder every year to update it. It is in part a recruitment tool, and for studies not enrolling any more (DCVAX-L), this is irrelevant. When we put our study on there, we agreed to post results when known. DCVAX has no results, so nothing to post. There is no law involved with failing to update the site. If you receive NIH funding, you are out of compliance if you do not update, and risk losing NIH funds. For a company funded study like DCVAX, the listing is in a sense voluntary (for recruitment and to have a listing to refer to when publishing results, which most journals now require). Since the DCVAX trial was listed a priori on the site, they will be able to refer to this in the final results pub. No problem there. Failure to update does not violate any laws, but it would be poor form if results arene't posted when known.
Ex - DCVAX L study has not bee enrolling for over 2 years, and no results, so no updates.
That's a nice little article. Shows how the company may have come up with their predicted RRR around 23% also.
Skita - ClinicalTrials.gov has to be updated annually to reflect enrollment changes, and with results when they are known. Neither of these apply. The study is just "still ongoing - no results." That is probably why there are no updates.
Ferret - See AVI's recent post. For a high impact paper like this, journals want to maximize impact, so can do some things to get publication (at least electronically) done quickly, for example, to coincide with some other event like AHA. Normally it would take at minimum 4 weeks to get something accepted (typically longer), and that assumes no revisions are needed. Obviously, Bhatt could not write the paper before he knew the results, but some have stated they think he may have had access before the top line announcement (as PI on the study). Assuming best case scenario and they had a paper ready for submission shortly after topline (as suggested by JT's comments), there is about a 6 week window for the review and electronic publication process. Assuming the editor picked reviewers who were aware of the need for speed, this is plenty of time to get initial reviews done and sent back to the authors, a revision quickly prepared, and any re-reviews that are required done. The journal would then have to work with the publisher to get the proofs set more quickly than normal and returned for review/correction by Bhatt before the electronic version of the pub could be made available. Tight timeline but possible.
AVI - Thanks. I would not be surprised at all if this happens (good to know of a precedent). It would be terrific if it played out this way.
Don't they have a huge amount of tax loss carryforwards to offset profits for a while?
Zip - I am sure the pub is already being reviewed. JT said shortly after 9/24 that they were already in discussions with journals about publishing the results.
No - 10 minutes is correct. These were short slots reserved in advance for late breaking news. They will only be able to present highlights, but should report the key SE data we all want to see. More details will be in pub shortly after that.
So now BB are up to about 47 million shares?
I wondered the same thing - they gave shares to their subsidiary, which means they gave the difference between the conversion price and market PPS to themselves, in a sense. Maybe they have totally separate financial systems so they can't use these proceeds as their own even though it is a subsidiary.
Makes sense. Good point.
Dan - What are your thought on whether this might actually increase the PPS short term? It would seem to reduce uncertainty about further dilution from pending secondaries.
I think I understand - dilution technically but value of the company is unchanged.
Even weirder is that although the site has not been updated officially since 2016, the Translational Medicine blinded article is listed on there (added sometime recently).
What's weird is that this seems to be notes held by a wholly owned subsidiary of Amarin (Corsicanto)- so this almost seems to be an in house financial deal. Not sure if this an actual dilution or not.
Statistics Schmatistics....If the company waits much longer, they will be reporting OS based on actual deaths in the whole sample rather than needing any inferential statistics.