You beat me to it Raf. Du is not on the list tho

I’ll shoot you an email, I think I still have yours from Vegas

I’ve been lurking but not much to post about in the doldrums of 2020. No longer in the service, making moves to break into a new industry. I was always too restless for the full 20.

Hope you and Mrs. Beer are well!

Couldn’t help noticing that either. Sure miss it...

Re: AMRN being in play - it’s more likely than not in my mind. This management is good but to try to commercialize a very misunderstood product on two continents while fending off the generic hordes is absurd.

The absence of substantial PR about anything resembling a pipeline also signals an intent to sell once value has been sufficiently unlocked. How many multi-billion dollar biopharmas don’t have any mention of a pipeline on their website?

I think the question is how much value unlock justifies the risk of delaying the sales boost that selling would bring.

“Source of the complaint is the destruction of billions” of equity value that the management team helped create. In times like these let’s not take comedy for granted

Yea I was surprised how readable it is, especially if you’ve been following the worthwhile posts on this site the last month or so.

The differential effects for trigs over/under 500 was put forth in a really compelling way. Thanks in advance to the experts who I’m sure will chime in

Lem I’m not hopeful about a timely vaccine either, but we don’t need that Hail Mary, we just need a therapy that can bring the mortality down to a reasonable level. Or to discover that the mortality is already at that level and we simply weren’t aware, though I’m doubtful of that notion. All is not lost (yet)

I believe north is referring to judge Du’s pretrial order, which marjac posted to the board back in December.

The bottom half of my post 260136 and post 260137 attempt an explanation if you want to read more. Disclaimer: I was tired when I wrote it so it’s not the easiest to read

No it’s just not relevant to AMRN or the market. 3 weeks is f ancient.

Zum,

Seriously this is weeks old. I do appreciate all you’ve done for this board though

Ah I see your point. I agree should, but not too confident about the would. It’s an interesting thought that a generic label should warn against prescription for CVD. I can almost imagine that prescribers might be dissuaded from off-label prescriptions based on fears of malpractice.

Of course then there’s a new issue: what happens when the reduce-it patents expire? FDA might be in a precarious position in 2030 when generics seek entry to the broader market.

Additionally, the label they would be seeking is based on MARINE, so that’s the data they would need to demonstrate bioequivalency to. I’m not sure how they would handle bioequivalency claims for an outcomes-based trial like Reduce-It, as opposed to a biomarker trial like MARINE. I guess they’d look at serum EPA as the relevant information.

In laymen’s terms, the generic must be 80-125% equivalent to the brand, article below that spells that out in greater detail. The capsule could likely be engineered out of the problem. For example more epa in the generic capsule (slightly larger pill size). Generics can be innovative too, when they must. Especially when obtaining their bio-equivalency data:

https://www.pharmacytimes.com/contributor/timothy-o-shea/2016/06/debunking-a-common-pharmacy-myth-the-80-125-bioequivalence-rule

https://www.cbsnews.com/news/ranbaxy-whistleblower-reveals-how-he-exposed-massive-pharmaceutical-fraud/

Noticed that as well

So for the legal folks still hanging around, am I crazy or did Judge Du violate her own pretrial order? And knowingly employ an erroneous methodology?

Found a case with notable similarities to our circumstances:

https://www.finnegan.com/en/tools/in-re-cyclobenzaprine-hydrochlorine-extended-release-capsule/analysis.html

What’s particularly incredible to me is that the specific error mentioned in the Sherkow call today, burden-shifting when evaluating secondary considerations of obviousness, is explicitly mentioned in Judge Du’s pretrial order.

Google: amrn iHub cyclobenzaprine and you’ll find marjacs post and go to paragraph 234. In that paragraph it clearly cites the federal circuits rationale for overturning a district judges error for using the same erroneous methodology that Judge Du employed

Trust me I took an ass-whooping like everyone else yesterday. The judge will have to weigh the merits of granting an injunction, and that will take time.

IMO, expect no injunction. Whether it’s activism or corruption, the generics seem to be favored until the appeal manifests.

Injunction requested does not equal injunction granted. Not an expert but an injunction granted in < 24 hours seems like fantasy

Pax, I think markman is very wrong in their conclusion that generics wouldn’t at-risk launch. Generics slit each other’s throats to be first in the market because that gives them a huge head start on market share, and market share is almost everything since they don’t compete on price or quality in a meaningful way. Unless there’s an injunction, they will be chomping at the bit to launch. They are effectively competing for cashflows in perpetuity by securing market share today.

Lots of bad news, but better to be honest and face the painful reality.

Not in Michigan...

https://www.detroitnews.com/story/opinion/2020/03/26/opinion-michigans-doctors-fight-coronavirus-and-governors-office/2922272001/

Was reflecting on the 5 stages last night

I am concerned that the haphazard response measures of individual states is going to drag out the timeline of the US fight against Covid-19. Just check out Gov Ige’s address to the state of Hawaii last night: national news reported that he ordered bars and restaurants to close, but if you watch the conference it was actually a request, with some vague hints at enforcement. Hawaii’s law enforcement is way undermanned, with just 2100 officers; they can’t possibly enforce this in a timely manner.

What happens if they shut down state borders? The economic disruption could easily last 6 months, and the damage for multiples of that.

The silver lining is that AMRN remains a smart bet, especially once the litigation is handled. Not a lot of downside from a market cap of < 4B if you’re patient.

Ps: don’t lick anything at that Marriott, there were two confirmed cases there last week. Hope you guys enjoy your visit though!

Funny how no one is still seething over JTs massive offering back in the summer.

IMO his conservative approach has postured the company quite well: substantial cash reserves, no premature launch of DTC, and modest sales force expansion that keeps overhead manageable... but what do I know?

Sign me up. I’m too young to be this weary

Exactly. My problems seem pretty small right now. Gut-wrenching to watch the missiles track to our bases without being able to do anything. Praying that casualties are minimal but they launched TBMs not 107mm rockets...

I appreciate him. He allowed me to dump 3k shares at $20, in exchange for a boatload of dec 22s and jan 23s :)

Congrats everybody! Saw the posts about the halt right as my flight took off, what a long flight...

Three-point MACE plus all cause mortality. Did they post-hoc combine secondary endpoints?

Better link: https://www.fiercebiotech.com/special-report/nash-four-letters-and-a-multibillion-dollar-opportunity

More or less the same article but links at the bottom for quick summaries of leading NASH candidates.

No specific mention of AMRN, but a good overview of the NASH race:

https://www.fiercebiotech.com/biotech/why-do-we-need-a-nash-drug-nash-leaders-weigh

9 years and kiwi is finally waking up

Absolutely. Maybe some time at a poker table as well.

Ditto brotha

Very interested, and I think a trigger is a good idea. Hopefully soon

KOD is another baker bros holding on a killer run

Lol exactly. It’s what gets marz thru the week

Via terrapharma:

Harvard Medical starts new study (11/21/19) using Vascepa to prevent colorectal cancer $AMRN

PRevention Using EPA Against coloREctal Cancer (PREPARE)

"hypothesis that EPA modulates the gut microbiota to preserve colorectalic immune homeostasis and suppress colorectal cancer"

Vet,

It’s a lot of anonymous employees (presumably) speculating. Like you said, we are all blind. So are they, just read their comments.

Everyone contributes to this forum freely, it’s not some kind of merit system. I contribute what I best can, and hope to pay it forward.

Ps are you mad bc I promised a tour of Pearl Harbor? There was a fellow in Vegas... maybe this is worthless speculation...

A. Probably not ‘his’ “DD” since I saw it on ST first

B. He brought data, I brought analysis

C. Why you always wanna fight

Worthless speculation. Blind leading the blind.

Happy bday brotha! Much better this time around... looking forward to evaporate for mine

I’d say 9. 10 would be reserved for a 15-1 vote regarding primary and more reasonable perspectives re: risks of bleeding/afib vs CV death (based on what our resident MDs have stated).

Granted I could only watch a few snippets here and there bc of work, so most is hearsay. Tomorrow should be fun and now thru Q1 should be a blast.

With a broad label very much in play, hiring should be full bore; if not, more is in play