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Collectively, the petitions included more than 20,000 signatures.We write to you as individuals and families who suffer from Amyotrophic Lateral Sclerosis (ALS) to request final revisions to and publication as soon as possible of the Food and Drug Administration’s (FDA) Draft Guidance document: “We are among the thousands of Americans suffering from ALS. There are, however, an increasing number of potential breakthroughs that provide us hope, not only for those living with ALS, but also for those living with a myriad of neurological diseases that During the multi-year process related to this Guidance, FDA repeatedly professed to be “very much aware of, and sympathetic to, the needs of patients with debilitating diseases such as ALS.” Yet despite telling Members of Congress that it is “actively working to finalize the ALS Draft Guidance and hope to do so expeditiously,” FDA has repeatedly kicked back the date for the publication of this Guidance.

Last we heard, FDA has now indicated that it “hopes” to publish the Guidance before the end of the year. At a certain point, words, no matter how well-intentioned, become meaningless.

We recognize the Guidance alone will not cure ALS, but it is an absolutely critical first step.

On a July morning, Billy Joel watches through the window of the study at his Long Island estate as a helicopter takes flight. ” It’s a week before the singer and erstwhile songwriter’s record-setting 100th concert at Madison Square Garden and Joel, dressed in a baseball cap, black T-shirt, plaid shorts, and sneakers, plops down on a leather couch. It didn’t always used to, but now, pushing 70 years old, it does,” he says. Mozart wrote more than 40 symphonies; Beethoven wrote 9. By the time I got to my 12th album, I didn’t think the quality trajectory was going to continue to go up. My understanding is that you’ve been chipping away at that for 20 years. You know, there’s an album Columbia put out called , and it was unfinished stuff that never should have been heard. I refer to that album as “Twigs and Stems and Seeds” — you’re not supposed to smoke that shit. Over my career I’ve been ] — the classical critics take you apart with a scalpel. The critics didn’t scare me off from releasing new material. Had I been younger and still recording it would have bothered me because it was so wrong. But with the authentic thing, he [Springsteen] is a guitar player and the guitar is the definitive rock-and-roll instrument. ] “Raise up a multiplex and we will make a sacrifice.” This biblical imagery skewed by consumerism — I’m proud of that. I still get thrilled listening to the Beatles and the Stones. In between pieces, he began to explain that these were variations on a motif and that they were telling the story of the history of Long Island, from its pastoral beginnings to the arrival of the Europeans — ‘I’m imagining the prow of a ship, and a Puritan hymn’ — and then the bustle of the nineteenth century.” : “Onstage, he’s a lounge lizard, whipping himself into an artificial frenzy to put across some kind of warped version of what he imagines, say, Bruce Springsteen, Neil Young or the Clash stands for.” All these years later, to me anyway, the idea of comparing a pop-centric songwriter like Joel to the rockier Springsteen, let alone the Clash, feels a little apples to oranges.

If I’m having a tough time hitting notes — I call it throwing junk pitches. If I’ve got to throw too much junk, I’m going to consider stopping. It’s funny: Sometimes I don’t think we did a good show and I’ll read a great review and go, “Was this guy at the same show? I talked to Sting and [Don] Henley: “Why are you still doing it? I was always trying to feel like there was a real progression in my work, and eventually I realized I was only going to be X good. You work so hard on your stuff and you want people to hear it. I keep getting, “He doesn’t challenge the audience enough.” Oh, they’re not challenged enough by paying 150 dollars for a ticket and wading through puke to find a seat? That is, the figure includes gigs he played prior to the start of his residency.

It would be abhorrent to me to be up there faking it. “That’s what I do.” But I made a lifetime out of it when I thought maybe I’d have a couple years, so I’m not complaining. Like I said, I couldn’t be as good as I wanted to be. It couldn’t be throwaway Christmas shit like Elvis used to do. ” So your motivation to write new music was about external validation? It bothered other people: Randy Newman was underrated. The most important thing is giving the audience what they paid for. I’m thinking of that line in “Summer, Highland Falls”: “It’s either sadness or euphoria.”Maybe that’s how I felt that particular day. But if you talk to people who work with me, I think they’ll disagree with me being portrayed as a depressive. The 100 MSG shows total is derived from all the concerts Joel has given at the venue.

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