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    “They’re crazy!” That’s what they’re saying about us. The majority of the people in America at this time in history do not channel spirits, do not converse with angels or aliens, do not astral project, do not know about any kind of higher vibration, and do not talk a
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    bout Starseeds, Indigo Children, nor Lightworkers. They don’t know anything about ancient secrets being coded into crystals nor about the healing effects of various stones. The only animals they talk to are their pets and they don’t actually listen for any kind of a
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    esponse. They don’t talk to dead people. They have no idea what kind of a higher purpose or mission they might have been sent here to do. They have no idea what it is to have a voice from above speak to you and ask you to step out of the normal way of things to do s
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ome sort of holy spiritual work that will help guide or save humanity. They just go about their lives having no idea what it is to walk in our shoes. They call us crazy and sometimes it’s difficult not to agree with them.

    Be honest, don’t you find that you doubt you
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    own sanity at times? I do. I used to think I was the only one having this experience until the internet… now I know that there are millions of us all with the same flavor of insanity. I suffer from PNS Syndrome. That stands for Paranormal Nagging Spirits Syndrome.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    These nagging little voices are always telling me what to do and telling me to improve myself and to then go out and teach others how to improve themselves. It’s bad enough that they natter at me all of the time, but then they always insist that I have to go public
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    ith the whole thing. Yet, nobody else in the room ever hears them. I wonder how much longer until they make a little pill to make the voices in my head go away. Then I think about how lonely it would be inside my head if I didn’t hear them anymore. Every time I thi
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    nk about that pesky little ‘going public’ part, I find my sanity going out the window again. Can’t we keep this to ourselves? I just want to get along with everyone else who doesn’t here the voices.

    I read other people’s websites, magazine articles, and newsletters
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nd it amazes me how open and factual it all sounds. Hello! Did you forget that we are weird? Why aren’t you hiding? Wait until we have more real tangible proof! Then I remember all of the pioneers that came before us. What must it have been like for Lewis and Cla
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    rk to travel across this country and bring back far out wild stories that the East Coast folk could hardly believe. This must be how it feels to be a pioneer in any field of study, whether it’s exploring uncharted territories, studying Quantum Physics, decoding DNA, o
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    walking on the moon. The normal everyday Joe sits back with this bewildered look on his face saying, “No way!” There’s always that element of “Wow! I wouldn’t believe it if I hadn’t seen it with my own two eyes,” as we share our discoveries with the rest of the wor
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    d.

    I remember back to the first couple of years that the voices used to come and talk to me. I was terrified to tell anyone for fear they’d lock me away in a little pink padded room. My poor children would be left orphans because their mom had gone insane! After ma
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ny years of making those guiding voices prove themselves to me over and over again, I finally came out of the closet so to speak and began telling my closest friends. They didn’t think I was nuts. About three or four years ago, I finally came out to everyone and it w
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s amazing how many people’s faces lit up and said, “I know exactly what you mean, I thought I was the only one they talk to too!!” I even ran a radio ad for my company based on those little voices in your head and had an overwhelming response from other speakers, writ
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ers, and healers who all came forward saying they heard them too.

    I’ve seen too many things and had too many people come forward with stories just like mine, not to believe something or someone is out there helping us. The voices in my head have proven themselves cor
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    ect and loyal too many times for me to doubt them. I was miraculously led to discover all of these amazing paranormal teachings and concepts all by myself. Then, I was shown books stating that every single thing those voices ever taught me were ancient wisdoms that m
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ankind has been aware of forever. Here I was thinking I was all holy and special only to find out that they’ve been doing this to us since the beginning of time. I have nothing new to say and neither does anyone else who is teaching this stuff.

    Isn’t it natural to f
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    el crazy and insane when pioneering into areas that are unknown and different from what we’re used to? Can this many people really be crazy with the same mental health problems? Do we all have some sort of Joan of Arc Complex that makes us create the illusion that we
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    ’re here to help and maybe even save these people? Do we just sell snake oil to ourselves saying it’s some sort of magical elixir? Well if I’m crazy, then please don’t save me. I love believing that I’m the kind of person who steps up to the plate and does the impos
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ible. I love believing that I was put on this planet to make a difference. I love being that kind of person. Don’t cure me of my fantasies that magic really happens. If this is crazy, then so be it. I’m in good company.

    Copyright 2003, Skye Thomas, Tomorrow’s Edg


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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