After a complete response letter (CRL) for the cataplexy indication was issued by the FDA in August 2019, Harmony met with the Agency in December 2019 to discuss the deficiencies cited in the CRL. WAKIX is administered orally, once daily in the morning upon wakening.įDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. WAKIX, a first-in-class medication, is a selective histamine 3 (H ₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. He is also the co-founder, with Jeanne-Marie Lecomte, of Bioprojet. Professor Schwartz is the discoverer of histaminergic neurotransmission in the brain and the histamine-3 receptor, which is the target receptor of WAKIX. This approval highlights the recognition by the FDA of a new therapeutic option in the treatment of the two major symptoms of narcolepsy by a drug with a novel mechanism of action," said Professor Jean-Charles Schwartz, PhD. "From the very beginning, our passion at Bioprojet has been to bring WAKIX to people living with the daily challenges that are associated with impaired wakefulness and the risk of cataplexy attacks. "At Harmony, we always keep patients at the heart of all we do and with this approval, we are inspired to continue our mission to develop novel treatment options for those living with rare, neurological disorders who have unmet medical needs." ![]() Jacobs, Harmony’s President and Chief Executive Officer. "This approval underscores our ongoing commitment to support people who are living with narcolepsy," said John C. "Today’s FDA approval of the cataplexy indication for WAKIX, coupled with it being the first and only non-scheduled treatment option approved for adult patients with narcolepsy to treat both excessive daytime sleepiness or cataplexy, provides an opportunity for WAKIX to offer broad clinical utility to healthcare professionals managing adult patients living with narcolepsy." ![]() "All people living with narcolepsy have excessive daytime sleepiness and up to two-thirds of them also experience cataplexy, which is one of the most debilitating symptoms of this chronic, rare neurological disorder," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Food and Drug Administration (FDA) has approved WAKIX ® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. ![]() ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, PA and CHICAGO, IL, OctoHarmony Biosciences Holdings, Inc. WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy
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The industrial estate and facilities of Chemical Plant No. The area houses a customs terminal, fuel storage facilities, offices, and dorms, as well as a variety of other infrastructure and buildings. Unlike the minefield, once blown up another doesn't respawn in its place allowing claymores to be permanently cleared after detonation.Ī large area of industrial park land situated adjacent to the factory zone. The mines on the bridge to the lighthouse can be passed safely with an encoded Digital secure DSP radio transmitter. They are currently only used on the Lighthouse location, scattered on the bridge to the lighthouse at the peninsula territory and on the hills eastern of the water treatment plant. The mines have an activation range of 5-10m and instantly kill players upon detonation, unless they are behind cover. ![]() They are used to create artificial borders on Customs, Lighthouse, Reserve, Woods and Streets of Tarkov.Ĭlaymores are anti-personnel mines. It is therefore essential for survival to retreat immediately when being targeted by one, as taking cover is pointless. They should be avoided under all circumstances, not least because the player's health will be set to 1% after dying to them. They are invisible, non-killable and can shoot through any object. While they are used to create artificial borders on Woods, they can also be found scattered around the water treatment plant on Lighthouse and along the harbor terminal wall on Shoreline.īorder Snipers are marked by various warning signs. It is therefore impossible to detect a mine, let alone clear a minefield. The mines are invisible, respawn after they detonate and can only be triggered by players. Minefields are usually marked by warning signs, but there are also a few unmarked ones (e.g. The Inactive Account Manager can help you manage specific content and notify a trusted contact if you stop using your Google Account for a certain period of time (between 3-18 months). ![]() ![]() To learn more about how to remain active with these products, visit this Help Center page. Learn more about how to keep your account active Google Workspace, G Suite for Education and G Suite for Nonprofits policies are not changing at this time, and admins should look to the Admin Help center for storage policies related to their subscriptions.
![]() When reviewing a taxpayer's return claiming such deductions the Internal Revenue Service will look at expenditures first as non- deductible personal expenses and allow only specifically documented medical expenses. Section 213 specifically excludes a deduction for cosmetic surgery or other similar procedures unless the surgery or procedure is necessary to ameliorate a deformity arising from or directly related to a congenital abnormality a personal injury resulting from an accident or trauma or disfiguring disease.When combining travel for medical purposes with tourism determining the amount of the deductible portion can be problematic. Therefore it is possible that the $50 per person deduction may be used for funds paid for room and board at a hospital or medical care clinic while obtaining healthcare overseas.A deduction is also allowed for transportation expenses of a nurse or other person who can give injections medications or other treatment required by a patient who is traveling to get medical care and is unable to travel alone. ![]() ![]() Therefore you may deduct the cost for certain types of medical procedures obtained overseas.Medical care is defined in part as amounts paid for the diagnosis cure mitigation treatment or prevention of disease or for the purpose of affecting any structure or function of the body and for transportation primarily for and essential to medical care.Ī deduction is allowed for up to $50 per person for each night for lodging while away from home primarily for and essential to medical care if such care is provided by a physician in a licensed hospital (or in a medical care facility which is equivalent to a licensed hospital) and there is no significant element of personal pleasure recreation or vacation in the travel away from home. Section 213 allows a deduction for expenses paid for medical care to the extent that such expenses exceed 7.5 percent of adjusted gross income. Internal Revenue Code Section 262(a) generally prohibits the deduction of personal or living expenses unless specifically allowed by the Code. Certain expenses incurred in traveling for medical purposes are deductible for U.S. ![]() Theįunction geom_point() adds a layer of points to your plot, whichĬreates a scatterplot. You complete your graph by adding one or more layers to ggplot(). Interesting so Iâm not going to show it here. Ggplot(data = mpg) creates an empty graph, but itâs not very The firstĪrgument of ggplot() is the dataset to use in the graph. ![]() ggplot()Ĭreates a coordinate system that you can add layers to. With ggplot2, you begin a plot with the function ggplot(). Does this confirm or refute your hypothesis about fuel efficiency In other words, cars with big engines use moreįuel. ![]() The plot shows a negative relationship between engine size ( displ) andįuel efficiency ( hwy). To learn more about mpg, open its help page by running ?mpg. With a high fuel efficiency when they travel the same distance. A car with a low fuel efficiency consumes more fuel than a car Hwy, a carâs fuel efficiency on the highway, in miles per gallon with 228 more rows, and 4 more variables: #> # cty, hwy, fl, class mpgĬontains observations collected by the US Environment Protection Agency Variables (in the columns) and observations (in the rows). A data frame is a rectangular collection of You can test your answer with the mpg data frame found in ggplot2 Ggplot2::ggplot() tells you explicitly that weâre using the ggplot() If we need to be explicit about where a function (or dataset) comesįrom, weâll use the special form package::function(). You only need to install a package once, but you need to reload it every Library() once again: install.packages ( "tidyverse" ) library ( tidyverse ) If you run this code and get the error message âthere is no packageĬalled âtidyverseâ,â youâll need to first install it, then run It also tells you which functionsįrom the tidyverse conflict with functions in base R (or from other That one line of code loads the core tidyverse, packages that you will Will use in this chapter, load the tidyverse by running this code: library ( tidyverse ) #> Loading tidyverse: ggplot2 #> Loading tidyverse: tibble #> Loading tidyverse: tidyr #> Loading tidyverse: readr #> Loading tidyverse: purrr #> Loading tidyverse: dplyr #> Conflicts with tidy packages - #> filter(): dplyr, stats #> lag(): dplyr, stats To access the datasets, help pages, and functions that we This chapter focuses on ggplot2, one of the core members of the ![]() They’re gonna want their favorite animals occultist. Everyone’s gonna want their favorite animal. James: I wanted to make as many people happy as possible. Did you kind of just go to town with animals and creatures that you wanted to see in the game? Or did you kind of look at it look at and go like, Okay, someone would want, for example, a cult full of fish people and unicorns? There’s also this whole customization of the cultist that you can do. Justin: Okay, so you’ve managed not only to create all these NPCs and bosses that run the gambit from adorable to terrifying. So I think that was one that I really liked, and it came together nicely and was super fun and tricky to animate as well. So it was quite cool to sort of bounce ideas between the two of us, and he did this weird sort of squid thing, and then I liked the idea of him sort of hiding these massive tentacles underneath his robes and then having all these multiple arms that will have different weapons in it. He designed those four bishops, and then I did the mini-boss version. And those four bishops were a bit of a collaboration between me and Julian, the creative director. I think Kalamar, Who’s the third boss, the boss of the water area, where he has lots of tentacles. Justin: Did you have a favorite character, creature, or boss that was your favorite to design? So once we decided that, the programmers would come up with prototypes for the bosses, see what was fun to fight, do the art over top of that, and consider how they would look as a follower. In reflection, it would have been nicer to tie the follower and monster designs to different animal types. So then, at that stage, it kind of started bearing in mind when designing the monsters. ![]() So initially, I was just doing the monsters and the bosses. That was an idea that I think came at sort of midpoint in the project. So did you find yourself designing both of those simultaneously? And was there one that was more difficult to find that balance with than the others? Justin: speaking to like the bosses, like you mentioned, after we beat a boss, it turns into basically like a cute version of that boss. And then, when you fight the mini-bosses and beat the bosses, you recruit them to your cult. ![]() So it kind of made sense for the monsters you also fight to be animals, but the kind of monstrous twisted version of those. So we kind of ended up basing everything around animals, which went well with the themes. So yeah, we were very kind of very wary of going to far into that sort of demonic, gory, gruesome, monstrous designs. So we do have the kind of rituals and curses and sort of magic stuff, but we wanted it all to sort of fit within that kind of pagan, very naturalistic direction. So some of the bugger inspiration were, of course, the film Midsummer, and also Wicker Man, and those kinds of pagan, Wiccan, folklore vibes. And we wanted it to be a little bit more grounded in reality. But we kind of realized we didn’t want to go too far down the gory or gruesome, and we tried to find the balance. So we kind of had a bit of push and pull there. So I would draw things, and then Julian and Jay, the other two directors, will be like, it’s too cute, make it eviler, and more monstrous. So there’s definitely a struggle early on. I’ve always leaned towards the more cute and colorful stuff. Okay, so were there any designs that leaned too far one way or the other? That juxtaposition really started to sort of pop. But while still keeping our eye on our signature cartoony style was a plan early on when we landed on the theme of cults and the kind of idea of starting a cult with worshipers and then having the kind of dark world that you kind of got to explore. ![]() So we always wanted to bring in the horror elements and a darker side to layer on top. And I think that may be limited our audience to a degree. With adventure pals, one of our previous ones, we had a lot of people saying that it’s a kids’ game. James: I think we’ve kind of always had quite a cute sort of cutesy cartoony art style to all our previous games. Justin: So what’s the plan always to kind of strike this mix of the cute and macabre? Our main character, the Lamb, is the perfect example of this, so when given the opportunity to sit down and have a chat with James Pairmain, Art Director at Massive Monster, regarding Cult Of The Lamb, I jumped at the opportunity. Finding The Balance Between Cute And Horrifying: Cult Of The Lamb Interview With James Pairmain Art DirectorĪfter playing Cult Of The Lamb, one thing that stood out to me, and I’m sure everyone else, was this incredible mixture of dread and cuteness in almost every element. ![]() 415 Kumi Nation only recruited black inmates from California's Bay Area, but now recruits from Black gangs all over California. There are documented KUMI members in every Prison within California. They began using the Swahili word "KUMI" (Koo-me) meaning "10" (the sum of 415 is 10.) Since the creation of KUMI, they have grown in numbers. (KUMI AFRICAN NATION ORGANIZATION), the founding members became unsatisfied with the BGF leadership, so they broke away from BGF and formed 415 Kumi Nation, which is the area code for parts of California's Bay Area. Prior to the creation of KUMI or K.A.N.O. Gang Identifiers: 5-pointed star top hat martini glass Playboy bunny dollar sign cane Handsigns that form the letters “VL” Gold, black, and red colors University of Iowa, Pittsburg Steelers, and Penguins attire Louis Vitton (LV) caps UNLV Jackets (UNLV- VLNU reversed, Vice Lord Nations United)Ĥ15 Kumi Nation was formed in the mid 80's by members of the Black Guerrilla Family (BGF) at San Quentin State Prison. Members are actively involved in numerous criminal activities including murder, drive-by-shootings, and weapons smuggling. Sets can also be found in Central America and Spain.Ĭriminal Activity: Members of the Vice Lords are primarily recognized for their drug trafficking activities and violent acts to protect their drug trade and territory. Location: Vice Lord sets have been confirmed in 28 states in the United Sates, the primary location being Chicago, Midwestern states and Eastern cities. Although recent attempts to unify the various sets under one umbrella organization have been unsuccessful, the gang, collectively, is becoming more sophisticated and organized. The Vice Lords are a predominately black gang consisting of numerous gang sets each with its own leadership and rank structure. Although endemic to the Chicago region, the Vice Lords have expanded into neighboring states to advance the gang’s criminal activity, and currently sets have been confirmed in 28 states, with a nationwide membership of nearly 35,000 members and associates. ![]() The gang has an estimated 20,000 members throughout the state, both in prison and on the streets. Membership/Hierarchy: As the second largest street gang in Chicago under the People Nation alliance, the Vice Lords represent a major force in Chicago and throughout the state of Illinois. The gang was formed for protection and profit. Originating in south Chicago, Illinois in 1958 by a group of black juveniles who had met at the Illinois Training School for Boys in St. History: The Vice Lords are the oldest and currently one of the most dominant and organized criminal enterprises in the state of Illinois. Vice Lords, aka: Vice Lord Nation, Conservative Vice Lords, Imperial Vice Lords, Insane Vice Lords, Four Corner Hustlers American Pie: Song That Might Play When You Fight Sans - Undertale, Song That Might Play When You Fight Sans (Alternate Mix) - Undertale, Earthbound - Super Smash Bros.Main Theme: Biggest Fan (As Performed on American Idol), Biggest Fan (American't Idol).Judgement Day: Judgement Day (Dusk Impulse Mix).Characters: Main Theme (Angry Birds) - Angry Birds Trilogy, Berdly (NTSC Version) - Deltarune.Level 1: AGENT OF THE COSMOS ~ X & VIII. ![]()
![]() You won't know what works well on you (and with your wardrobe) until you get out and experiment (or earn one as a gift or through joining. Step into a shop - try some hats on explore different pinches swap a hat with a curved brim for one that's nearly flat. If you can't get one custom-made, commit to trial and error. That being said, there are a number of ready-made styles, too, from Stetson, Greeley Hat Works, Burns 1876 and others. It's the most popular show on television, and many of the cast members are wearing custom-made pieces. It's hard not to point to Yellowstonewhen discussing the cowboy hat's comeback. There are pointed, round, flat, wide and extra-wide fronts, and they generally dictate the shape of the rest of the brim, if they follow tradition, that is. The easiest way to identify a brim is by its front, though. But unlike curved and flat, there are far more names: Half-Taco, George and U are all names for the same style, which has a flat front and high, pointed edges. Just as baseball caps come with curved or flat brims, cowboy hats are offered in myriad shapes. ![]() ![]() The most popular pinch is the Cattleman, which you'll find employed on hats from Stetson, Greeley Hat Works, Burns 1876 and a bunch of others. That means it fits one way and one way only. A pronounced pinch, on the other hand, doesn't offer much vertical room inside the hat. They'd push them down when the wind picked up. Tall crowns, for example, were for riders who wanted to ensure the hat would stay on their head. Different ones serve different purposes, but we'll point them out when they appear. It's where you grab the hat to put it on or take it off, hence the name it's where you pinch it to pick it up. Pinch / CreaseĬowboy hats come with different crowns and features - a.k.a pinches (or creases). An 8, on the other hand, is for someone with a 25-inch noggin. The range starts at 6 or 6 1/2 and runs all the way up to 8, usually, and sizes outside this spectrum must be special ordered.Ī size 6 works on someone with a 20-inch circumference head. If you've ever bought a fitted lid before, whether a baseball one from New Era or a fedora from some fine hat maker, you know how measurements go. It's a lighter material that's typically constructed with an open weave. Strawįor sun protection with built-in breathability, many opt for straw hats, which are made from natural palm. Pure beaver felt can be a little pricy, which is why cheaper alternatives are fashioned from wool felt. Felt hats prove capable of protecting the wear from wind, rain and snow, both because it's warm and water resistant. When you set your hat down, put it upside down. Take your cowboy hat off when you’re indoors. Wear the right cowboy hat for the right season. The most ideal Western hats are made from fur felt crafted from pure beaver. Some standard, base-line points of etiquette: When to remove your cowboy hat. |
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