Category: "Narcolepsy/Cataplexy"

Prescription Drug User Fee Act -- Patient Focused Drug-Development -- Docket Number FDA-2012-N-0967

Link: http://www.gpo.gov/fdsys/pkg/FR-2013-04-11/pdf/2013-08441.pdf

Last year the FDA soliciting public comments to narrow down the diseases to focus on for its Patient-Focused Drug Development Initiative, which has the goal of obtaining the patient's perspective on certain disease areas during the five period of the PDUFA (Prescription Drug User Fee Act) V. To assess a product's benefits and risks involves an analysis of the severity of the condition treated and the current treatment options available for the given disease. This information is a critical aspect of FDA's decision-making as it establishes the context in which the regulatory decisions are makde. The FDA believes that drug development and their review process could benefit from a more systematic and expansive approach by obtaining the perspective of patients on disease severity and current available options in a therapeutic area.

They had nominated 39 diseases, where narcolepsy was one of them, and were looking to narrow the list down to 20.

And, the result is Narcolepsy got selected! :cool:

Even though there were directions on how to make the comment anonymously, I choose to include my name and I had gone with greater emphasis for Narcolepsy since it was my most recent diagnosis, and since it was first brought to my attention during the after dinner conversation aboard the Nautica Queen....though we Narcoleptics tend to have more than one thing wrong...and perhaps someday I'll get to know what my current problem is called (something I've had over over 10 years now, but only started getting really bad the shortly after the conference.)

The conference was October 19-21, 2012...I got back on the 23rd, and wrote the letter on the 24th. Since I had book Wednesday to Wednesday off from work for the conference....

The resulting list for FY 2013-2015 are: Alpha-1 antitrypsin deficiency; breast cancer; chronic Chagas disease; female sexual dysfunction; fibromyalgia; heomphilia A, hemophilia B, von Willebrand disease, and other heritable bleeding disorders; HIV; idiopathic pulmonary fibrosis; irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease with persistent regurgitation symptoms on proton-pump inhibitors; lung cancer; myalgic encephalomyelitis/chronic fatigue syndrome; narcolepsy; neurological manifestations of inborn errors of metabolism; Parkinson's diseases and Huntington's disease; pulmonary arterial hypertension; and sickle cell disease.

There will be another public process to determine the list of disease areas for FY 2016-2017.

Wonder what the future meetings will be....

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Suddenly Sleep Saturday in March 9th

National Sleep Awareness Week, this year takes place March 3-10, 2013, is an annual public education and awareness campaign to promote the importance of sleep. The week begins with the announcement of the National Sleep Foundation's Sleep in America poll results and ends with the clock change to Daylight Saving Time, where Americans lose one hour of sleep. The Foundation's Sleep Care Center members host events in their local communities throughout the week, providing sleep education and screening to the public.

The last Saturday of the week, is known as Suddenly Sleep Saturday and is also known as Narcolepsy Awareness Day.

On the last Sunday in 2011, March 13, Julie Flygare held the first SLEEP WALK in DC. This year the (3rd Annual) National Sleep Walk is today, March 3rd. Perhaps some day I'll travel for it....

Meanwhile, last year other Sleep Walk events started up across the country and around the world. Some for this year include:

SLEEP WALK West Coast in Sacramento, CA
SLEEP WALK Hawaii in Waikiki, HI
SLEEP WALK Dallas Texas

And, there are other events planned for Suddenly Sleepy Saturday, such as a Narcolepsy Bed Race in Roanoke, VA or Ireland's first International Narcolepsy Awareness Day:

I did something amazing this morning

I've been having trouble with getting packages delivered to my home for some reason lately....recently found out that apparently, they've been leaving my packages outside at the wrong address...where the unit in that condo building was vacant for the last part of January and seems to be getting work done to it now.

Two deliveries lost, that I know of. Since I get other deliveries without notice, I might not know that I'm missing something. In the first case, I got an email from UPS Surepost saying the package had been delivered by the post office...but I got nothing. The second time, was for CPAP supplies from CPAP.com, so I was tracking its progress. When it showed up, I wasn't home so they left a note. I asked for it to be redelivered, but nobody showed up with it. Later I found it to be marked as delivered. After calling USPS to find out where it is....I got call from supervisor saying the carrier came to my address, knocked and left it. But, nobody knocked on my door at the time in question.

And, I was sitting by the door at the time in question....I was on the phone for the February Midwest Narcolepsy Support Group meeting, which ran past 12pm.... so couldn't get supervisor to explain why there was no knock. The next day, a UPS delivery person mentioned that he had seen packages for me left at another address, said I should go check it out. There wasn't anything there....but since then I found another person that confirmed that packages were being left there. Hinted that if they hadn't been picked up by somebody else, they might have gotten hauled off the dump with the construction debris that had been piling up by the door.

Fortunately, two shippers that I know of, agreed to send me replacement shipments. The first wanted a different address to send the shipment to, so I provided them with my UPS Store address. That might take a while to get, since I originally ordered the item on January 4th, and it didn't ship until January 17th and allegedly get delivered on January 23rd...it was surely too large to fit in parcel locker.... It was one of those special purchase sites, for greatly discounted one day sale...so I'm surprised that they would replace the order. CPAP.com chose to resend using the same method to the same address. It arrived yesterday, and apparently after 5pm (5:05pm), but I wasn't home, since I aim to catch the 5:38pm bus home....and in general typicality it was running late. I thought about requesting redelivery...for Wednesday, since I had plans for this afternoon, and didn't want to risk wasting the whole day waiting for a no show again, etc. Plus I only sent an email about what I found out last night, so I don't know if they would've done anything to fix it yet.

After some thought though, I decided that what I might attempt to do, is get up early on a weekend....which is challenging, since I'm still sleeping on Daylight Saving Time. Doesn't help that I spent 8 nights on PST and 4 nights on MST...where not changing my CDT sleep schedule fit with sleeping in those time zones. Not sure what kind of schedule I'm going to sleep on when I spend some more time in PST.

And, be really early...and try to catch the 9:02am bus to the mall....get a haircut, do some shopping, indulge in a Smashburger, before visiting the post office before it closes at noon on Saturday. (M-F 8:30-4:30 and S 9:30-12:00). Well, I slept in a bit, and things moved slower in some areas than expected. In the end I missed, in it taking longer than expected to find two matched socks.

So, I opted to catch the 10:02am bus. It was running a touch late....and after the student union it was packed...people got left behind packed. Large groups of students going to Dillons East on Saturady.... So, I got off at the mall, got a aircut, did a little shopping before and after...and then decided to go to the post office to get my package before deciding if I would either do SmashBurger or catch the next bus home. There was quite the wait at the post office, I guess I don't know what its like, since its been more than 5 years since I was there. And, the last time was to renew my passport.

When, I came out it was about 20 minutes before the 11:30am bus back home....I didn't really want to be carrying the package around and didn't feel like I would enjoy having not enough or too much time at Smashburger either way. So, I waited for the bus to show up and ride it home. It was a pretty empty bus....2 people the whole way back...and then there was one.

So, home before USPS would typically show up...and there's some packages that should arrive today...so I can wait and see if those arrive correctly.

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I got an Eye Exam

So, since my Narcolepsy Diagnosis, I've been having vision problems...since September. I suspected that some of it was due to my medication, and I did find that I was right...but learned from Facebook before the NN Conference in October that what I was experiencing was more associated as a side effect of my stimulant than the other. I might be starting too strong with it in the morning.

Making a change on that front, brought about an almost immediate improvement....and while at the conference, I learned of another thing to adjust and that also made for a pretty quick improvement.

However, I still felt that my prescription had changed...but didn't feel like I could get an eye exam and new glasses done in time for LISA, so I put it off....except I guess I put it off too long...because I finally got the eye exam today....but, I'm off to Gallifrey One next week. Not enough time to get a new pair of glasses. Manhattan, KS needs an 1 hour place....though do they do computer progressives in an hour? No, I need my own time machine.

For the progression...see "The Result of my Latest Eye Exam"

And, then after the eye exam, the doctor remember that I had done poorly in the upper left quadrant of my left eye in the peripheral vision test, and that he would see how I did to see if there is concern.

I again did poorly in that area. Said this kind of thing usually points to Glaucoma, but my eye pressures are perfect so that doesn't. So, he's not sure still...though he did notice in the up close exam of my eyes that my left eyelid does hang longer than my right, so maybe that's impeding my ability to see in that quadrant. But, he recently got this new machine that can quickly determine if it is and he had checked my insurance and saw that I had met my deductible. (Getting my Xyrem refilled on Jan 2nd, made me meet my $2500 deductible really quickly....and it didn't hurt as much as I thought it would either...) So, the extra test would be full covered. The normal eye exam portion is covered 100% and not subject to deductible....as are other defined preventive exams....

Meanwhile, I'm wondering if a pair of prescription sunglasses will work into my plan this year? Since the change is much, and given how I bought 3 new pairs of glasses last year....and only have the one pair. I should have a spare.

Perhaps, I might revisit Transition lenses again... for one of the pairs.... :hmm: Though so far I haven't made any use against my limited use FSA, which I had considered lowering, but in the end had kept at the same level of funding this year.

But, first how will I get by at Gallifrey One.... guess we shall see... :roll:

Home Brrr Home

Well, I'm home from another trip from the freezing north. Its a tad cold in my home too, good thing my flight from DFW to MHK was delayed, otherwise it would probably be colder.

When did I schedule the vacation hold on my thermostat? I was sure I had done it just before 8pm the night before I left....setting a 5 day hold, so that it would expire well before I got home. But, evidently it had gotten super cold in my home so it took a long time to recover. It was 62 when I got home, and it is try to get to 68......based on how much its gone up in about 45 minutes...I guess it has been working since around 8pm to get up from 50 (where I had set the hold at, I'll probably need to rethink the vacation hold bottom.)

Meanwhile, I found my missing smartphone. I didn't leave it plugged in...in the hallway like I thought I had. But, I had remembered to pick it up from there, but I had set it down when I had stopped to unplug my hot water pot....and forgot it there.

As for how the flight home went...leaving Calgary for DFW was uneventful. Going through customs was somewhat easier thanks to Global Entry, though I'm not sure why I don't also have Nexus....wonder what's involved in getting that added. Though the trip into Canada was relatively painless this time. Though I did get picked for secondary screening before security.... And, seems they subject ultrathin computers to secondary screening as well. The picked on the thin macbook product of a person ahead of me...and my chromebook, but they didn't test my thicker Lenovo laptop or other beasts that I recall for people around me. Though was kind of annoyed that Chromebook always turns on when you open it...a complete shutdown really should leave it off. It didn't seem happy about starting to turn itself back on from the complete shutdown, and then getting closed. But, airport security just wanted to swab the keyboard.

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