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I am very interested in MRKR; I've been through their data and various presentations; I bought a small marker position yesterday (and promptly lost 6% on it). The technology is clearly game changing.
I find this concerning:
"VITAL will explore whether vitamin D and Omega-3 fatty acid supplementation is effective in the primary prevention of cardiovascular disease and cancer. The Omega-3 result will be interesting to look at in comparison to REDUCE-IT, as REDUCE-IT is using a more purified form of a fish-derived substance—and a higher dose—in an attempt to lower lipids and reduce cardiovascular events."
So whoever wrote this thinks that somehow these two trials can be compared, when they were conducted in completely different populations. My concern is that if this trial is positive some poorly-informed people are going to think that it somehow extrapolates to the secondary prevention/T2DM population.
Damn it that means that Vascepa obviously won't be in this iteration of the guidelines. They will likely issue a "focused update" next year instead that would include Vascepa.
That looks about right to me.
Oh, I'm not saying that it will not be significant (I hope it is), just that the P value is not going to be as low as CV death. Also more events does not mean a lower P.
I think the idea that Amarin is a fraud is hilarious.
You'd have to get literally dozens of people both inside and outside the company to agree to potentially career-ending fraud and very expensive litigation for...what exactly?
Tasty, the statistical significance of overall death would be very unlikely to be greater than that for CV death. It is always the least likely to be statistically significant because the effect of the drug would be partly obscured by all of the other non-CV causes of death that Vascepa would be unlikely to have an effect on (cancer, respiratory disease, traffic accidents, falls down stairs, etc, etc).
***At 25%, hard MACE is announced as p < .001 (really much lower), CV Death (if 300 of them) is p = .012 (strong but not crazy stat sig), and overall death (if 500 of them) is p just above .001.
I would love to see their rationale for any price target above $5 for KURA.
Yeah I love those "Gates Foundation invested 1.5 million" or "BB invested 5 million" headlines.
However I am actually carefully evaluating MRKR as a possible investment now--the technology is quite compelling from the 15 min I've had to look into it so far.
I'm back into biotech, albeit not in a big way. I have 80% of my portfolio either in cash or passively invested. The remaining 20% will be devoted to biotech.
Along with AMRN as of Monday I am a RVNC shareholder too. Looking actively for 1 or 2 other interesting opportunities, one of which might be MRKR.
First that is a very poorly done fake criticism filled with lies and writen by someone who does not understand pharmaceuticals.
Second, the website itself was created solely to post that criticism. And it is called "medscapeinfo" -- clearly with the intent to defraud gullible people.
No it wasn't--the power calculation is made for the primary end point.
It doesn't mean that it couldn't be significant...but all of the end points above it in the hierarchy would need to also be significant.
I'm sure you guys have already discussed this here ad nauseum but the statisticians literally go down the list, and as soon as they hit an end point that is not significant, every end point after that is also not significant.
We'll see how far they make it down the end point list! I'm hoping for all the way.
MRKR's technology looks great.
The problem, of course, is that if you're treating a relatively rare disease with a therapy that is that inexpensive you're not going to be making all that much money.
This does seem worthy of further investigation though.
Yeah the med-reg team is different from the ones pursuing patent litigation.
Yes of course! But it would be very supportive.
I noted that the latest presentation confirms "Top line result supported by robust demonstrations of efficacy across multiple secondary endpoints."
Now if this were a big pharma company with a legal team breathing down their neck and clearing everything they say "multiple" would mean at least 3 secondary end points. Which in turn would mean, given hierarchical testing, that at least all of the following would be statistically significant:
Composite of CV death, nonfatal MI, or nonfatal stroke
Composite of CV death or nonfatal MI
Fatal or nonfatal MI
But since Amarin is not a giant pharmaceutical company with a large legal team breathing down their necks, they may be less cautious with their language.
Regarding the publication turnaround time: It's actually pretty normal for urgent publications like this. It's likely they hired a professional writer, who put together a skeleton paper prior to the results coming out, and then as soon as they came out the writer dropped the data into the skeleton.
Nope I'm not sure at all. I've worked on guidelines and many publications before. If they are truly being released in Q4 of this year, that means that the final publication is already at the journal and being prepared to be published.
So one of 2 things will happen:
1. They will publish the guidelines as is, and issue an update that will probably come out early next year (I think this is most likely)
2. They will pull the guidelines from the publication process and revise appropriately. This is not a trivial or quick task, because they need to get everyone on the guideline committee to agree. In this case the whole publication would be delayed.
I don't know what they are going to do though. I'd prefer #2 as then Vascepa is enshrined in the actual guidelines instead of in an update that people may or may not read.
So for the Q4 documents, it is unlikely that new data from REDUCE-IT will be in them, as they are likely already in press. What they often do when there is a paradigm-changing result is quickly issue an update to the guidelines which might be as short as 1-2 pages and could come as soon as Q1 of next year.
However, I feel like the REDUCE IT results are important enough that they could possibly delay the release of #1 and #2 to consider and include these data. I don't know--trials that are this significant don't happen that often to predict how they are going to react to it. Unknown territory.
If it does get a recommendation in the guidelines, it is possible that expanded coverage will follow from insurance companies regardless of when the formal indication is granted by the FDA. If this does happen, it likely wouldn't occur until after the full peer-review publication is available, which will presumably be before the end of the year.
4 major AHA/ACC Clinical Documents are in Progress, In order and approximate time of release:
1) Blood Cholesterol (Revision) expected Q4 2018
2) Use of Risk Assessment Tools to Guide Decision Making in Primary Prevention of Atherosclerotic Cardiovascular Disease (Companion Article to Blood Cholesterol Guidelines) expected Q4 2018
3) Recent Innovations, Modifications, and Evolution of ACC/AHA Clinical Practice Guidelines: An Update for our Consistituencies expected Q1 2019
4) Prevention of Cardiovascular Disease expected Q1 2019
That's the Vindico one that I couldn't find, so it's a different symposium. The titles are promising though.
Just FYI at most CME events about 25% of the audience is from industry, so you can bet that representatives from all potential partners or acquirers will be attending.
Clearly if they only gave them $2.2 million they're just taking a flyer.
I've worked with some groups under the Gates umbrella and their levels of competence are quite variable from best and brightest to quite average. So I'm not sure I'd take funding from the Gates Foundation as an unalloyed positive.
Strikes me as an absolutely terrible idea.
This strategy is obviously great for people with deficiency diseases (like hemophilia), not so good to produce therapeutic proteins.
I believe this is Medtelligence agenda
http://events.medtelligence.net/2018/Apr27/Meeting-Details-4-27-18.pdf
Oh wait I take that back...that's a program from April.
Still looking...and here it is for AAFP
http://events.medtelligence.net/2018/Oct11/Meeting-Details-10-11-18.pdf
And here's the AHA one
http://events.medtelligence.net/2018/nov11/Meeting-Details-11-11-18.pdf
I just want to note that in all likelihood this agenda was completed and published at least 2-3 months ago so I'm not sure it provides any useful information.
Can't find the one for Vindico.
Usually for CME they publish the agendas in advance (because physicians need them in order to decide whether they are going to attend). According to the press release "The organizers are Medtelligence and Vindico, respectively."
Let the hunt begin.
Please keep in mind I'm talking out of my butt here since I haven't done any research yet, but one might expect the incidence of anti-dMAb antibodies to be lower than exogenously administered antibodies because all the normal post-translational modifications are going to be in place and they are thus less likely to elicit an immune response.
Can someone help me understand, though, what the point of producing therapeutic proteins and antibodies endogenously is? Why bother, especially for therapeutic proteins?
Just want to point out that there were endless, endless investigations and studies of statins to examine benefits beyond lipid lowering and while they were interesting, none led to indications or really even bumped the use of statins. I suspect that it's going to be much the same case here.
I mean be happy with a 25% reduction in MACE, that's already super impressive.
Yes I had a small position prior to the top-line, and I bought more immediately after the results were announced.
As to why I know about Lipitor marketing--I developed a lot of it over more than a decade--from the time Pfizer first acquired Lipitor until the very last managed care sales aid; I wrote publications and convened investigator meetings, etc. So I know a bit about the space. I wish Amarin would call me so I can help them market this properly
I'm not going to speculate on how much AMRN is worth (a few here have ridiculous expectations, others are more realistic). But I do think that this is likely a paradigm-shifting drug in the lipid space, although final confirmation of that will come in a few weeks. I do believe there is still a lot of room to run just based on the topline result.
Lipitor was only marginally more effective than simvastatin, and rosuvastatin is actually more effective than Lipitor.
Pfizer's magic was in two things: 1) superb marketing and 2) maintaining an ongoing commitment to funding major clinical trials to continue to explore the effects of statins. These two things go hand in hand -- many docs liked Lipitor because of that commitment to continued research, and the continued research generated additional data to support Lipitor's use.
Ask me how I know this.
Yes I'm not sure where they would go from here assuming that they stay within their core competencies. Cardiovascular is a tough market and all of the big indications have lots of generics, leaving only niche markets.
I could see, possibly, a combo pill with a statin a la Caduet.
PS: Hi!
I haven't really started investigating yet. Give me some ideas to look at?
I think you all are assuming that the biosimilars will be hugely less expensive than the branded treatments. They won't, so I don't expect Humira sales will take the kind of hit small molecules do when they go generic.
There are also very significant questions as to whether "biosimilars" are really all that similar. I think these concerns are justified, unlike the argument that Pfizer's small molecule is somehow better than Teva's small molecule.
That may be true for moderate levels of genetic instability but SCLC is extraordinary in this regard; enough so that there's a virtual guarantee that somewhere in the tumor cell population there are going to be some cells that can escape PD-1/PD-L1 inhibition.
I just realized that the new NCCN SCLC guidelines that came out yesterday are recommending Genentech's anti-PD-L1 in the first-line setting for SCLC. Maybe targeting PD-L1 is more effective than targeting PD-1? If you were to ask me in the absence of any other data I would say that the opposite would be more effective.
No, I haven't been paying close attention.
I think SCLC is going to be intractable for another few decades. The problem is that it is highly genetically unstable, so resistance is going to be generated quickly to almost anything that is thrown at it.
If anyone ever comes up with something that is truly effective in the second-line SCLC setting it's going to be a major advance.
SCLC is an exquisitely chemo- and radiosensitive cancer, so first-line responses to things like carboplatin + etoposide are amazing (like 87% PR + CR). Unfortunately patients rapidly and universally relapse relatively quickly and die of the disease. Unfortunately, there are few if any targetable mutations in SCLC so developing a targeted therapy in this indication is going to be difficult.
I guess the only take-home from an investment standpoint is be very cautious of any company developing a treatment for SCLC, becuase it is unlikely to be effective.
Nice to "see" both of you again.
So I pretty much quit biotech investing; although my returns were reasonable, doing it well was almost a full time job in and of itself. Plus I didn't have enough capital to make it worthwhile relative to spending that time on my job. I was basically invested passively throughout the Obama years and up until about a month ago, which turned out to not be a bad strategy.
I've started to slowly sell off my ETFs; unfortunately not fast enough not to get whacked over the last week but better than being fully invested.
In any case, I have enough capital to make it worthwhile now. So we'll see what happens. I had and still have some fun money invested in pot stocks (ACBFF and CGC) and AMRN, all of which have done quite well but my investments were quite small, unfortunately.
Hi!
I have the deepest respect for Republicans who can clearly elucidate their rationale for their political choices, even if I strongly disagree with their platform.
My point is that, at least in this election, the Republicans' base appears to be people who can't string together a logical thought. Like Sarah Palin.
Rarely is the question asked, is our children learning?
>Do you know the difference between closed-end and open-end funds<
Yes. I meant NMD.
My point is that muni funds are almost never so volatile, even if they're leveraged, as the majority of closed-end muni funds are.
In any case, I'll quit cluttering the board with this.
Thanks Dew and CHM.
I find it surprising that a municipal bond fund is on the Reg SHO list.
Interestingly, NVD down another 6% today, which is very, very strange. I don't care how leveraged a municipal bond fund is, or if it just went ex-div, it shouldn't lose 20% over a matter of days unless there's something really wrong. It's currently yielding ~9% tax free.