I suspect that patient compliance will be better when Vascepa is prescribed by a cardiologist rather than a GP; however, I question how many of even the sickest Vascepa patients will follow through with their doses day after day, indefinitely

More challenges for biotech investors are not necessarily a bad thing, as you suggested in your bottommost paragraph.

This is 2018. The SEC knows how this shit works now.

Get ready for jail time, scumbags.

I have seen it(Pomerantz) start an investigation at least a dozen times on legit stocks and not so legit stocks after a pump and during the dump.

I think most people now believe there is cell killing with TKIs too. When you disrupt the mutation driving the cancer apoptosis may kick in.

VKTX AASLD data:

https://www.prnewswire.com/news-releases/viking-therapeutics-presents-results-from-phase-2-study-of-vk2809-in-patients-with-non-alcoholic-fatty-liver-disease-nafld-and-elevated-ldl-cholesterol-in-oral-late-breaker-presentation-at-the-liver-meeting-2018-300748744.html

Comments:
https://twitter.com/gcbioinv/status/1062135499232632834

Quote:
Herper's article in particular was borderline journalistic malpractice--just embarrassing.


Yeah, I don't think it was borderline, that was a ways in the rearview mirror. I just wanted to try and explain the process a bit. It's sausage-making, and good journalists--I know a couple--have a sense of where the line is, and work to try and present the full story of whatever they're covering, as opposed to advancing a perspective. These days there's a lot more of the latter everywhere, and Herper and Feuerstein are exhibit A for financial journalism.

Pretty sure Feuerstein has never taken a journalism class; not sure about Harper. There are ethical standards you're supposed to follow, but no enforcement mechanism I'm aware of.

Are you familiar with what VXRT is doing?

I expect that Herper and Feuerstein gave snippets verbally for Nissen and others quoted to give feedback on.

First Universal Flu Vaccine to Enter Ph3 Trial

https://www.the-scientist.com/news-opinion/first-universal-flu-vaccine-to-enter-phase-3-trial-65073?utm_campaign

Numerous experimental vaccines that aim to provide multi-season protection are in human studies.

Who will be the likeliest acquirer IYO?

>> Personally my money is on TKI and ADC since I think both hold promise in combination with PD-1s which may not be fully appreciated by the market


I agree with that completely. In short to intermediate term, combination with proven drugs and mechanism is the way to go which is why I say MRK opportunistic. Roche have a lot more than just IL-2 variant alone. They investigated then abandoned several popular IO targets quickly that proven right later.

Band of Brothers update: They threw everything they had at us today and got less than 6%. We're still here so f*ck them.

Following that logic, the most cost beneficial thing society can do is to take everyone who turns 65 out and shoot them. Then turn them into soylent green.

I'm confident you're correct, rfj. I recall another student at the Kennedy School undertaking an analysis on the cost-savings of different health care interventions that we might pay for as a society. Measures that people think of as saving tons of money--smoking cessation, for example--don't pencil out. Many adult-onset interventions don't pencil out, because they allow us to live longer in retirement, spending society's wealth on our Social Security and medicare/medicaid.

Spending on kids pays off well; you don't want to invest in kids and have them depart before they start paying taxes.

There can be savings if you have a better treatment that allows someone who would otherwise be disabled and need more expensive care to be healthier and need less or no care as a consequence.

Cost savings Explained-

Savings is directly related to number needed to treat. That’s what everyone looks at.

NNT is 21 for Vascepa. Outstanding. Unbelievable. Most drugs not even close to this.

BP control NNTs

1 in 125 were helped (prevented death)
1 in 67 were helped (prevented stroke)
1 in 100 were helped (prevented heart attack*)

Get lost. End of story

I believe the number to treat to save one life was 20. So 20 patients on Vascepa costs how much? and one fatal heart attack with ambulance, ER, IC etc and then death and funeral expenses costs how much? Vascepa wins.

This weekend I learned that some people get very angry when you write about mineral oil.

Cost savings from preventing 30% of nonfatal strokes and MIs will outweigh costs of the drug by an enormous amount.

The article says it will cost the healthcare system $9 billion to put people on this drug. Strange that they didn’t mention what it might save in healthcare expense. That’s why I thought when I read it the first time that it was sponsored by someone not friendly to us.

If the drugs can be combined w PD-1s effectively (easier said than done) then that could transform a drug from "incremental" to "innovative". It also has the added commercial benefit of setting the PD-1 apart from the pack so could really lead to a large premium in any BD deal.

AZN’s oncology pipeline is weighted toward “targeted” agents rather than I-O, so I’m not sure “exciting” is the most apt description. Imfinzi is distant fourth in the PD(L)-1 category.

AMRN -11% on AHA presentation of REDUCE-IT; I presume this selloff will be relatively short-lived, but who knows?

Apparently, because now we have ANCHOR and R-IT to confirm, taking mineral oil concurrent with statins probably impedes their efficacy somehow

i've had a BO before when amylin was bought out by Azn and Bmy. personally i think the odds amrn being independent by next yr are rather slim. what do you think ?

Relationship between on-treatment high-sensitivity C-reactive protein (hsCRP) and the primary and key secondary endpoints

thank you for your contribution to this forum btw

how these were addressed with different prespecified analyses

On the log-transform hsCRP analysis, Nissen said, the data in the manuscript that show a large increase of CRP with the mineral oil placebo "is the 'official' result. Mineral oil is probably pro-inflammatory, which is a major problem with the trial."

Quote:
AMRN—…the Forbes guy [Matt Herper] is *really* digging to find reasons to doubt the result but not doing any digging whatsoever to see what measures were taken to address these issues… I also find it a little disturbing that he is presenting a trivial increase in LDL-C in the placebo arm as something to be highly concerned about.
I’ll concede that there may be modest bias against REDUCE-IT among some of the top biotech people I follow on Twitter insofar as few, if any, of them predicted success. The former head of R&D for a Big Pharma (and someone I follow on Twitter) told me this in August:
Quote:
I have no real scientific evidence, just observations over the years. Getting a positive CVOT result is a big hurdle. Fish oil to date has been uninspiring. Niacin (which admittedly has multiple effects) also doesn't have a CVOT benefit. Would a high dose "super fish oil" suddenly work? Maybe. But I wouldn't bet on it.
However, I wouldn’t knock Matt Herper, who is one of the best biotech beat writers. Matt doesn’t scrutinize technical papers on his own; rather, he calls experts in the field for comment, as he did in this instance. Some of the posters on the AMRN iHub board are going wacko with their accusations against Matt and others.

BTW: Technically, tertiary endpoints can’t be considered statsig unless all secondary endpoints have been met (in hierarchical order). Since REDUCE-IT’s lowest-ranking secondary endpoint—all-cause mortality—was not statsig (a close miss), there is no alpha for any of the tertiary endpoints.

Like Steve Nissen is ever going to say nice things about Vascepa

In this instance, the distinction we're discussing (raw hsCRP vs log-transform hsCRP) is a pretty small matter in the overall REDUCE-IT datatset.

Was that analysis really and truly prespecified? It’s not listed as one of the myriad secondary endpoints in the REDUCE-IT listing on ct.gov (https://www.clinicaltrials.gov/ct2/show/NCT01492361 ).

Bhatt also pointed out that a prespecified analysis of "log-transform" hsCRP

Bhatt also pointed out that a prespecified analysis of "log-transform" hsCRP did not show an increase in the placebo group. He explained that log-transform analyses are conducted to limit the impact of outlier data; hsCRP is known to have a high degree of variability, and extreme outliers are often seen.

"The REDUCE-IT hsCRP data fit the classic rationale for using a log transformation, with the nontransformed values showing a limited number of extreme outliers that heavily skew from normality," he said. "The log-transform analysis, which was just completed in the last couple of days, showed that the values fit a standard bell curve and show strong agreement with the line of normality. Basically, it shows when appropriately log-transformed, the hsCRP isn't increasing in the placebo arm."