Good summation. It does appear though that, based on previous FDA actions, there is always the chance that the FDA once again admits a mistake, this time regarding considering MO an inert placebo, and the ADCOM is about whether a DDI is necessary. I just don’t see any other potential negative reason for an ADCOM (if not the MO issue, then it’s all about label expansion). How long would a DDI take to establish certainty about MO interaction?

AVII77 deserves a huge thank you for his incredible work. Any and all of us who were close to being shaken out by all the craziness and scare tactics but for AVII77’s posts should share a % of our bounty with him once V gets expanded label approved! Thanks AVII77 ??

I really do wish someone with great tech sleuthing skills would track these clowns down and find out who is truly behind MRC. The high level/quality and volume of their misinformation makes me think this is a professional hit job. Question is by whom.

That’s a great question. The FDA should not accept any “scientific” information, even in the form of a citizens petition, without full transparency and identification of the petitioner. Frankly it’s absurd.

FYI: Seems AMRN’s motion for partial summary judgement motion was immediately followed by Dr Reddy/Hikma filing for full summary judgement. As posted by MRC 5 hours ago on twitter:

Medical Research Collaborative, LLC
@MedResCol
·
5h
(1/) $AMRN So exactly one day after joint motion to extend expert discovery, Amarin's attorneys file motion for partial summary judgement (see PACER). DRL/Hikma then immediately filed motion for full summary judgement. They had up to 30 days after discovery to file.

I’m not only asking for AMRNs sake, but also for we investors. I’d certainly like to know if it’s about label, or MO, or the issues raised in the ICER report (trial stats, etc) or some other trial design concern, or concerns about trial legitimacy. Each offers an escalating degree of concern. And no, I don’t think AMRN is necessarily prepared for everything, given how f’d up and corrupt the FDA is. Look at how Nissen et al blindsided them in the last adcom, and how subsequent SPA was revoked, then SPA appeals delayed and denied for over a year. Do you really think AMRN is prepared if FDA claims some preposterous allegation of impropriety in the conduct of the study? How can they be prepared for the preposterous?

Ummm, maybe I’m missing something, but all that did is tell me FDA will disclose its briefing materials 21-14 days prior to adcom. So while that’s better than 2 days, it still sucks and is unfair given that we must assume the adcom was called for SOME reason and is not just spurious. If I am truly missing something, please enlighten me, as I would love to be told we will know something material now instead of end of Oct/early Nov.

Truly sucks that AMRN (or any biotech) isn’t told why AC is required simultaneous with notice. You don’t convene an Adcom just because. Why can’t this be disclosed (even if they want to hold off on determining actual questions until 2 days prior)? Frustrating, as it would end speculation

Is this ICER commentary possibly the impetus for the FDA’s surprise AC call? Is it possible that someone at FDA read this report and said “uh-oh, didn’t think of that, let’s do an Adcom”.?? Nothing would surprise me.

Sad but true. Was hoping there was some requirement but guess FDA is making this shit up as they go

When must FDA advise of new PDUFA date? Is there any guideline for this? Will we know in few days or could it be weeks? So bizarre that we get AC scheduled for date beyond current PDUFA without simultaneous announcement of new PDUFA date.

Yeah, can’t help but wonder why now? Why not wait until after approval? What would be gained by doing this now rather than waiting literally just another 8 weeks or less?

Simply following the overall market dump due to carrot tops China tariff tweet.

Ha, great story! AH did indeed try to grab WL and lost, but walked away with a $2B breakup fee at least :)

Ah, name calling makes you a smarter man, eh? For your edification, the entire Warner Lambert company was bought by Pfizer in 2000 for $90B in stock. This only represented a 34% premium to their recent stock price. The entire company had revenues of $13B, of which Lipitor represented $3.7B. So no, Pfizer did not spend $90B for Lipitor alone. Not even close. And for not much price premium either. Try to have facts before you get schooled.

Second, just for shits and giggles, you think every statin taking human is going to start taking V? Heck, only half of statin-eligible people take statins. Adding another Rx costs money, so take up will likely be a fraction of the 40M statin users. Good news is that V can do great with only 5-10% take up. You can do the math from here (I think), but I’m sure you’ll disagree. No worries, I just like to be rooted in reality and probability, not fantasy.

And on that point, we agree. Was just having fun throwing out number to see who would get riled up. I will be happy anywhere between my reality and your fantasy number (and don’t think I don’t secretly hope for your fantasy ??)

Lol. So in one post you estimate 86B in total revenue over patent life, and in this post you think AMRN will get bought for 66B. Wow. You and shinook should start you’re own business consulting firm because every biotech on the planet will want to get that kind of deal. :)

Nah. No consortium needed. $15-18B takes the company (or should take the company)

What’s the net margin? Then figure from there

No reason for Jan puts. Whether PDUFA date is delayed or a negative decision is rendered, it will happen in Sept and your puts will pay off. If you sell and buy back in or just cash in on the puts and keep the underlying position, you can always buy new puts on that position dated around the next catalyst date.

LOL!

Agree with jf. Too many replies to comment on, but suffice to say ICER has demonstrated some strange rationale and perspectives in their recent reports. Agree that it could suggest DS as alternative, and as I’ve stated in past comments, I believe the 5 year look will show a breakeven economic cost. As for ICER’s impact: while I don’t believe it will impact FDA approval nor doctors willingness to prescribe because of V’s life saving benefit, some insurers may look solely at the economic picture and not grant highest tier reimbursement, which could dent V script/rev potential. However, since V only needs 10% penetration of the statin user population to hit roughly $6B in rev, I’m not overly concerned as an investor, as that translates into at least a double from here.

Agree with VuBru, but it will truly be a shame as the science seems to clearly support a significant benefit to anyone on a statin (and possibly even those not on a statin) regardless of trig level.

But how many different ways can you challenge the same patents? If the courts deny earlier challenges, how are subsequent challenges accepted?

LBL, fine reply and not coarse in any way. Appreciate any and all efforts at a civil discourse providing meaningful opinions. Btw, I am in the P&C insurance brokerage business, and my son just entered the industry at a large broker in their reinsurance division. He’s in a training course with 50 colleagues and he just told me he prefers the actuaries he’s met more than the brokers :)

Kiwi, no idea what the co pay would be, but for the purposes of the ICER study, it doesn’t matter, as it is focused on the net cost to the insurer, not the public. The number is also what the actual revenue would be to Amarin. I’m guessing at 1500, but I’m sure it’s close (maybe slightly higher, as I’ve seen estimates as high as 1800). With volume, I would assume that Amarin’s margins would improve as COGS directly drops and OPEX cost % drops, which would support exactly what you are suggesting Amarin may do with the Repatha comparison: make it easier for us to do volume, and we will lower your cost. LBL states that JT has maintained V is a volume play, so that mindset would clearly support the “Repatha strategy.”

LBL, see my just posted response to kiwi for further dialogue on /metrics. Regarding your response, sorry, but I don’t understand what you are saying. I’m specifically talking about the probable ICER metrics they will use to determine cost/benefit analysis. I’m not arguing the value of V and the potential revenue, I’m a believer, and I believe V will do $billions in peak revenue (in my estimation, $4-5B as a minimum without surprises in either direction). I’m simply saying I don’t think ICER report will provide as compelling a savings conclusion as others do. I think it will be closer to a breakeven cost analysis (Cost of V versus cost of treatment/procedures in untreated population). Direct cost comparison is all ICER and insurers cares about. Bottom line though, even if not compelling, I don’t think it will impact V sales, as saving lives trumps all, and insurers would be vilified if they didn’t support V at highest acceptance tiers.

LattyBird/Whalatane: Below is my response to a previous discussion on same topic

“for every 1000 patients treated for 5 years, approximately 159 MACE (major adverse cardiovascular events) could be prevented with icospent ethyl versus placebo, including prevention of approximately 12 cardiovascular deaths, 42 heart attacks (myocardial infarctions), 14 strokes, 76 coronary revascularizations and 16 episodes of [img][/img]hospitalization for unstable angina."

So how would economic value be calculated? 1000 patients x 5yrs x $1500 V cost = 7.5M. Average cost for the 159 events prevented=? Breakeven would be at roughly $47k per event. That’s breakeven before productivity loss, but assume that’s what healthcare system looks at. Is $47k a reasonable cost expectation per event.

So kiwi, your 47k number is on the money, but it represents breakeven from an ICER perspective. In past brief research (as well as several anecdotal posts here about personal CV event cost) it seems like 50k is a good average (remember, it’s an average, so there will be some issues/events that cost markedly less, and some that cost much more).

I think people are being optimistic that ICER will show significant savings. ICER is ridiculously conservative and possibly biased. However, breakeven (or even slightly elevated cost) is good enough for V, as it’s a life saving drug, and no one is going to argue against preventing death. In addition, if you were to add human productivity loss to the ICER equation, that would be a totally different story

Go to SA and read the various articles on INSG

IF the FDA is having one? Isn’t it mandatory? Doesn’t Amarin know?

That seems to be for generic drugs under ANDA. Not sure if it’s the same for sNDA. Could be, but just sayin..

Absolutely. Have to go full throttle as GIA until a BO is signed sealed and delivered. Can’t rely on “probably”

No, only 30 so far. 39 includes previous days. But they keep adding so who knows how many they will post today..

Fascinating study.

Interesting article. Does the noted value of DHA make Strength/Epanova more of a competitive concern? (Please keep the responses civil. Not a scientist or doctor, so really don’t have the expertise to understand this fully. Appreciate this site for the higher level expertise of JL, etc, and would welcome any insight)

Crazy, and frightening. But it truly speaks to the dangers of docs suggesting “fish oil” as an alternative to V due to cost, and why AMRN must go all-out in its campaign against “fish oil” alternatives. Both from an altruistic perspective (who the F knows what’s really in these OTC options) and from a revenue perspective: the majority of lost rev opportunity will probably be from consumers who, since they’re already paying for a statin and probably other drugs, seek cheaper alternatives that they are led to believe are similar so they can manage their healthcare spend. There are roughly 40M Americans taking statins, and a similar number with high trigs (>150). I know I’m stating the obvious to this board, but even assuming a significant overlap in these two populations, there is no reason, other than cost, that AMRN couldn’t see 5M+ people on V annually. The key is discrediting the OTC supplements enough to make people realize they are not a satisfactory alternative.

Good post bfost. Thx for the info and agree on V getting into guidelines immediately.

Interesting article about Dr Reddy. Read the consumer comments below the article (after the first few it gets interesting)

https://cen.acs.org/articles/95/i32/Dr-Reddys-struggles-meet-FDA.html

So how would economic value be calculated? 1000 patients x 5yrs x $1500 V cost = 7.5M. Average cost for the 159 events prevented=? Breakeven would be at roughly $47k per event. That’s breakeven before productivity loss, but assume that’s what healthcare system looks at. Is $47k a reasonable cost expectation per event?