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The same encapsulator in FL does that work for AMRN and Hikma, Catalent - not sure about DRL. So only one company makes capsules, but multiple companies supply API to AMRN - that's really what the EMA was looking at, the contents of finished product using various sources of API.
Not sure economically if there's a diff between a product with a 4 yr shelf life and one with a 2 yr shelf life - the drug is consumed well before expiration date.
Almost every FDA regulation is a "non-binding guideline", not a real rule or reg - yeah, that makes no sense but I've been aware of it forever. It's one of the reasons FDA was able to cancel the ANCHOR SPA - was not a legally binding agreement.
Aware of that - it happens *after* FDA approval of the ANDA - they don't really check generic quality levels after that unless they get specific complaints, and even then it can take years before they take any action. Logistically impossible to inspect and test the thousands of different generic drugs imported every year.
I am 99% sure GV had to meet some kind of peroxide specs so they were equivalent to the RLD, V. To say FDA would approve a generic for a drug that is highly sensitive to oxidation w/o requiring the manufacturer to prove it was stable and unoxidized defies common sense.
I wouldn't get hung up on someone's definition of family history of CVD - it's not like the doc will be mad if you say yes, he'll want to know details in order to ascertain your risk - IOW do his job.
Don't know what to think about that India website - didn't look into the company behind it - are they legal? Don't know how they could import V into the country either.
The heat didn't kill you? Geez, it's so hot I can't even play golf riding in a cart for 9 holes - been getting dizzy and almost blacking out (lose vision for a sec or two), the heat is frying my brain and body. Part of that is due to my health problems, but with so many code orange air days it's not really healthy for people our age to be working outside. This has been one of the hotter summers we've had in years - going on 3 months of 90+ days with no end in sight - no wonder the West is burning to the ground.
Stifel posted a note to investors about HLS being undervalued - said Jan V sales were $6M, May was $12M, June $14M - extrapolate from Jan, they added $2M/mo, total $54M, AMRN reported $4.4M in royalties for Q1/Q2 - that works out to be 8%.
Something about that ROW excluding China and EU - that $1B is potential revs from royalties - KM said they will partner in those countries:
Somebody may be breaking the law unless you meet one of the very narrow exclusions, like you're paying out of pocket - I assume the step therapy escape clause means you tried the generic and it didn't work, like how generic Synthroid doesn't work for everyone. MA has a very similar law for barring coupons when an AB rated generic exists.
https://www.hoganlovells.com/~/media/hogan-lovells/pdf/2017/2017_10_16_health_alert_new_california_law_limits.pdf?la=en
https://www.policymed.com/2017/10/california-passes-legislation-on-prescription-discounts.html
Neglecting inventory and accounts payable/receivable, cash burn from Q2/20 to Q2/21 was $88M.
How did you get past a PA for an off label scrip? The reason PAs exist is to prevent such scripts from being sold.
Did you find an anti-itch pill or cream containing that CTM ingredient I recommended? If the itch is intolerable, you could talk to your doc about getting a scrip for Vistaril - I take that when I (rarely) get really itchy hives from an allergic reaction.
I specifically said not possible for Part D plans - by definition a generic can never be on the same tier as a brand for Medicare.
2) demands something HN cannot provide in all cases - most Part D plans have 5 tiers, with 1 = preferred generic, 2 = no preferred generic, and 3 = preferred brand - it's literally impossible to have a brand and a generic on the same tier. There's also still the issue of what do you do with states that require generics regardless of skinny labels - doesn't directly involve HN, but CA also has a law that if a generic exists nobody can use a discount coupon - not just Part D patients, commercial patients are barred from using them too - that law also does not account for skinny labels, maybe because there's never been a situation like this that politicians could foresee, an old drug given a new indication that accounts for 90% of sales - they are not doing their constituents any favors barring V coupons in CA.
Really wish we had CLF's LG running our company - there's a man who knows how to get things done and slugs it out with the shorts and negative nannies who attack the stock - his CC's are instant classics - he's a fighter thru and thru - we need that attitude in our C-suite after JT just let every attack against R-IT slide.
Might want to take a look at SAVA and AVXL - both working on AZ drugs with good P2 results, and the latter also working on a Parkinson's drug with support from Michael J. Fox's foundation and NIH. Spec bets - I won't be throwing wads of cash at them like I did AMRN.
Since he's using $140/scrip he must be calculating AMRN's losses to GV, because we have no idea what GV nets to Hikma. Numbers should be close enough. In any case, I'm not sure damages are calculated by the profits the infringer made - shouldn't they be based on the profits AMRN lost? How was the damages in GSK/Teva decided? That will give you the answer.
Yes, the problem is the USPTO didn't specifically state AMRN's claim the IPE doesn't raise LDL while lowering Apo(b) was based on Kura, which is why Du mistakenly claimed the examiner didn't refer to Kura, despite it being the very first reference listed in the patent.
How does a settlement with Hikma prevent DRL from infringement? It doesn't - whatever API Hikma no longer needs could be sold right to DRL. Sort of agree HN would want to settle, but AMRN shouldn't - they'd have to sue every other insurer, no precedent set, and that's the last thing they want to do - need to tread a thin line between making sure insurers follow the rules and pissing them off so much they just drop V from their formularies.
Yes, I do expect them to pass on the savings - one of the early API suppliers was booted out or never allowed to supply API because their costs were excessive compared to the others - think it was BASF. The only company I can think of that can charge pretty much whatever they want for their products and get away with it is Apple, partly because that's a cult. If you look at what you get for your money with AAPL vs. Intel/AMD it's not even close - AAPL is ripping you off. If I had an iPhone, the final straw would have been removing the 3.5mm headphone jack - no ability to listen to your music in your car or house via a 3.5mm audio cable connected to a real stereo or powered speaker set is ridiculous.
HN won't be able to settle unless they can sever themselves from Hikma, or convince Hikma to settle as well - since they're being accused of different infringing actions it might be difficult to settle together.
Not the way I cook my burgers - I like them thick and juicy, almost purple in the middle (none of that 90-95% lean crap) - cooked rare, even with cheese and ketchup (the proper way to eat a cheeseburger), the flavor of that meat is easy to taste - and damn it's good! Been eating rare or medium rare burgers my entire life and have never gotten sick from one - biggest problem is that many places will not serve a medium rare burger, only medium, and nothing is grosser than tasting the burnt meat on the outside - plus it's carcinogenic. How anyone can eat well done meat of any kind is beyond me - it's dry, burned, and tastes nasty. Steak tartare is amazing if you can stomach eating raw beef, and I have no problem with that, although I could count on one hand how many times I've ever eaten it - just tastes better when the juices get flowing from heat.
I was almost tempted to reply "why use one of those PACER monitor sites that are sometimes incomplete and don't let you look at the filings themselves when you could just use your own PACER account?" - then I remembered I got hit with a $55 charge by PACER last month, first time they ever charged me in years. Forgot to limit how much I downloaded in a given month.
You just reminded me of something - at least in criminal cases, when motions to sever are granted it's usually because one defendant plans to testify against the other - so this denial removes HN's ability to rat out on Hikma and come to a separate deal with AMRN.
??? Of course AMRN doesn't make anything - I didn't imply elsewise - the companies that produce API for them *have* decreased their costs over time as things got more efficient over the years - that's why AMRN's margins have gone from the 50's to the high 70's since V first went on sale, COGS has dropped dramatically.
The current schedule, if it holds (a big if), shows trial starting in 2023 - throw in appeals it won't be over until 2025 unless there's a settlement.
GSK/Teva isn't settled yet - Hikma can't really lean on that right now.
So when does the judge confirm the magistrate's opinion, or is this now a done deal? At least she made it clear she understands AMRN's complaint against HN - their PA shows they know exactly who is getting GV for an infringing use - they are actively encouraging infringement.
C'mon guys - take the time to read that post again - Lizzy is wrong, this update is not about motion to dismiss being denied, it's for motion to SEVER being denied. Well hangon - Birdbrain then posts something about motions to dismiss being denied - that wasn't in Rob's original post - so there were actually 3 court filings made today?
Failure to State a Claim? That's nonsense. Two issues here - that one, and news that Healthnet motion to sever the cases was denied - that's good news, might be why the pps picked up this afternoon after being red this morning.
Something doesn't look right on that chart - as script count grows, and production efficiency should be decreasing costs, along with annual increases in retail price, the Rev to Rx number goes down - inversely correlated to script count - should be the opposite IMO. Those $186 and $165'ish Revs per Rx at scripts between 200k-400k are serious outliers - and half the data points in that 0-400k scripts are above the trendline. Just weird too make less money with the more you sell.
How do you propose convincing insurers to pay for it w/o an FDA indication for CV19? Many responded to increased demand for R-IT indication by slapping onerous PA's on scripts - they'd probably do that even more if off label demand for V increases.
Blasphemy! A burger without cheese is like a hot dog without mustard.
Fine - they need an EU approved encapsulator to avoid shipping costs - doesn't change the meaning of what I wrote - and they don't have one yet.
$400 is retail cost, not wholesale. WAC is ~ $137 to AMRN - but EU doesn't demand the same discounts/rebates as PBM's in the US AFAIK, although the governments do demand discounts, avg. is 50% off retail cost.
As of right now Catalent US is the only FDA approved encapsulator for V - AMRN would have to ship finished V caps from US to the EU unless they get an EU encapsulator FDA certified. Would save some pretty significant shipping costs, would cut out two trips - AMRN has a couple suppliers in the EU, way cheaper to keep it within the EU shipped on rail or truck than ships.
Dilution didn't go up anything close to 10% - the amount of exec comp in dollars did - 10% dilution would be 40M shares issued in one quarter for RSUs and options - I don't think an entire year even amounts to 4M shrs.