What a wonderful trip!
Lighten up Bob.
Are you disputing those as facts?
Mel wasn't working now is.
Mel wasn't running now is.
If those facts change I'll let you know. Just as I did with the ups and downs of HiCy.
I stand by number 3 though.
I nearly came to blows with my father when he called her 'lazy' in the midst of a bad relapse.
Still, interested to hear what Mr.Success's perspective on MS is.
Bob, you are sticking to the autoimmune theory to the bitter end (despite not following it to its logical conclusion and going for immune ablation like we did, remember) and that's your choice.
We had the balls to try something new and report back not just snipe.
You were interested in autoimmunity prior to your wife being diagnosed and you'll be the last clinging to the raft. That's your choice.
And guitarguy - there IS a separate forum. This one. If you aren't interested don't click on it. For example, I have no real interest in statins. I don't go in there berating everyone.
I'm not saying you do, btw.
Are you disputing those as facts?
Mel wasn't working now is.
Mel wasn't running now is.
If those facts change I'll let you know. Just as I did with the ups and downs of HiCy.
I stand by number 3 though.
I nearly came to blows with my father when he called her 'lazy' in the midst of a bad relapse.
Still, interested to hear what Mr.Success's perspective on MS is.
Bob, you are sticking to the autoimmune theory to the bitter end (despite not following it to its logical conclusion and going for immune ablation like we did, remember) and that's your choice.
We had the balls to try something new and report back not just snipe.
You were interested in autoimmunity prior to your wife being diagnosed and you'll be the last clinging to the raft. That's your choice.
And guitarguy - there IS a separate forum. This one. If you aren't interested don't click on it. For example, I have no real interest in statins. I don't go in there berating everyone.
I'm not saying you do, btw.
um I wasn't referring to you, no need to attack me. I am on your side. I think you need to settle down a bit.Jamie wrote: And guitarguy - there IS a separate forum. This one. If you aren't interested don't click on it. For example, I have no real interest in statins. I don't go in there berating everyone.
I'm not saying you do, btw.
I was nerely pointing out how some of these threads seem to get out of hand and get personal sometimes.
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chrishasms
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CNClear
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OK, I told myself that i wasn't going to get into this...but just one comment and then I quit...albeit, a long comment...
My job is as a Regulatory & Compliance Consultant. I am currently working for one of the biggest pharma companys in the world. I am dealing with the writing of electronic submissions (which is the only way to submit applications, as of June 09, unless you get an exception from the FDA, and that's only a temporary one) for new drug applications, new devices and one combo product. Within the submission process, I deal extensively with clinical trials that are part of the applications, life cycle management, etc...all of which have new Codes of Feneral Regulations and Guidances written to try to help you understand the CFRs...I even teach classes on deciphering the CFRs and Guidances...boring classes that even I can't make entertaining...but anyway...
If you guys want to have an intelligent conversation about them...go to FDA.gov and search on Code of Federal Regulations and the Guidances that go with them...make sure you have the most updated ones...that's the little 'c' in cGMP, it stands for 'current' Good Manufacturing Practices...lots of infomation...there will be more than a few that could possibly apply. That is always a good debate in one of my classes...but even then it would be narrowed down to arguing about ONE specic Reg. So, determining what does and does apply is, in itself, a tedious process, such as, the stents are devices...the procedure to implant them is something else...now if they decide to put a drug in the stent, such as J&J has done with heart stents, in the past...that's covered under 'combo' products...there's a lot to read and most quite convuluded and boring...and they are just 'guidances' the FDA does not tell a company what it needs to do to get a drug, device, etc. approved, they just give you (what they call) guidance. However, before all this gets set in motion, the company's R&D scientists will meet numerous times with the FDA before they get too far into a trial and then realize it isn't what the FDA will approve anyhoo...
To summarize and stop my pontification...if you want to continue with this arguement, you should really at least have half a clue about which you so stringently argue...none of you understand how this works and as amusing as you were for a while...I'm pretty sure, you've covered this very complicated matter in a very juvenile manner...sorry to break the bad news to ya, but yep...y'all sound ridiculous...it will take years and studies of all types...mostly stuff that is understood, honestly, by a very few smart scientists, statisticians, risk mitigators, etc...oh, and if you do decide to go look all this up, then dont leave out all the Guidances and Codes on "Risk".
So, if the point is that there will be clinical trials in the future? Many. Will they prove out one side or the other? Depends. Are clinical trials useful? You betcha...is this conversation? Not at all...
Sorry
...But if you do pursue this...you'll probably need what would amount to a whole new forum...
See how (not) interesting my diatribe was? And I do know of what I speak...if that gives you a clue as to why I had to put my two cents worth in, after I promised myself that I wouldn't...OK, ok, I'm really done now...
Lisa aka CNClear
My job is as a Regulatory & Compliance Consultant. I am currently working for one of the biggest pharma companys in the world. I am dealing with the writing of electronic submissions (which is the only way to submit applications, as of June 09, unless you get an exception from the FDA, and that's only a temporary one) for new drug applications, new devices and one combo product. Within the submission process, I deal extensively with clinical trials that are part of the applications, life cycle management, etc...all of which have new Codes of Feneral Regulations and Guidances written to try to help you understand the CFRs...I even teach classes on deciphering the CFRs and Guidances...boring classes that even I can't make entertaining...but anyway...
If you guys want to have an intelligent conversation about them...go to FDA.gov and search on Code of Federal Regulations and the Guidances that go with them...make sure you have the most updated ones...that's the little 'c' in cGMP, it stands for 'current' Good Manufacturing Practices...lots of infomation...there will be more than a few that could possibly apply. That is always a good debate in one of my classes...but even then it would be narrowed down to arguing about ONE specic Reg. So, determining what does and does apply is, in itself, a tedious process, such as, the stents are devices...the procedure to implant them is something else...now if they decide to put a drug in the stent, such as J&J has done with heart stents, in the past...that's covered under 'combo' products...there's a lot to read and most quite convuluded and boring...and they are just 'guidances' the FDA does not tell a company what it needs to do to get a drug, device, etc. approved, they just give you (what they call) guidance. However, before all this gets set in motion, the company's R&D scientists will meet numerous times with the FDA before they get too far into a trial and then realize it isn't what the FDA will approve anyhoo...
To summarize and stop my pontification...if you want to continue with this arguement, you should really at least have half a clue about which you so stringently argue...none of you understand how this works and as amusing as you were for a while...I'm pretty sure, you've covered this very complicated matter in a very juvenile manner...sorry to break the bad news to ya, but yep...y'all sound ridiculous...it will take years and studies of all types...mostly stuff that is understood, honestly, by a very few smart scientists, statisticians, risk mitigators, etc...oh, and if you do decide to go look all this up, then dont leave out all the Guidances and Codes on "Risk".
So, if the point is that there will be clinical trials in the future? Many. Will they prove out one side or the other? Depends. Are clinical trials useful? You betcha...is this conversation? Not at all...
Sorry
...But if you do pursue this...you'll probably need what would amount to a whole new forum...
See how (not) interesting my diatribe was? And I do know of what I speak...if that gives you a clue as to why I had to put my two cents worth in, after I promised myself that I wouldn't...OK, ok, I'm really done now...
Lisa aka CNClear
Ha ha this is the most awesome thing I've read on here in a while. Thanks so much for posting it. Honestly, it's the same way I feel about all the debate about CCSVI in general. I doubt anyone on here is really qualified to debate it. There are a lot of people who are qualified to hope it works out though.CNClear wrote:So, if the point is that there will be clinical trials in the future? Many. Will they prove out one side or the other? Depends. Are clinical trials useful? You betcha...is this conversation? Not at all...
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cheerleader
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- Location: southern California
I know, Lisa...we're all a bunch 'o yammering doofuses that write about stuff way out of our ken. But we actually learn alot here. If dignan hadn't posted the Zamboni last December 'cause he knew I had a crazy hunch about Jeff's vascular system, I'd still think CCSVI was just a weird acronym, and my husband would be asleep in bed instead of dragging me out the door for a date (at 10pm) (Hope you're having a fun weekend, Jamie. Why do your threads do this???)
We may be fools, but we get things done and have a bit o fun, too
cheer
We may be fools, but we get things done and have a bit o fun, too
cheer
Last edited by cheerleader on Sat Oct 03, 2009 8:56 pm, edited 1 time in total.
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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CNClear
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- Location: Near Atlanta, GA
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And God bless 'em for their tenacity and patience to take the time to do research and share it with the rest of us and their compassion and on and on...the people who make up this forum are truly the best!
I'm one of the ones holding on to the hope! I can't wait until this monsterous disease is erradicated!
(and thanks for 'getting it' and my sense of humor...)
Let's ALL get better soon!
Lisa
I'm one of the ones holding on to the hope! I can't wait until this monsterous disease is erradicated!
(and thanks for 'getting it' and my sense of humor...)
Let's ALL get better soon!
Lisa
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CNClear
- Family Member
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- Joined: Fri Aug 28, 2009 2:00 pm
- Location: Near Atlanta, GA
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Oh Cheer! No, please don't misunderstand...the last thing in the world I would want to do is to make you think that I think you're all doofuses! i have the utmost respect for everyone on here...especially, you,Marie and others that I am just too damn flustered to be able to name at the moment...please, accept my apologies if I offended you! I've sent information about both Jeff and you all over, hoping to help...I've read every posting from the beginning and followed Jeff's story with intense interest and been keeping you all in my prayers...I've been to your websites...both yours and Jeff's music is beyond beautiful! I appreciate your taking the time and energy to go and do all that you have...I know I'm babbling now, but I never meant to offend anyone! I just got too comfortable, I guess...thought that I was getting to be one of your group...this sounds so sappy, but I really mean it...all of it! Do I have to go wait in the car now? 
Lisa
Lisa
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CNClear
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See what you guys did? Got me in trouble!
Just kidding...
Sorry, radeck and all... didn't mean to sound so condescending...i really didn't mean it as bad as it came out...shouldn't have taken my bad day out on y'all...
Sorry, rokkit, for trying to drag you in, too...
If anybody is looking for me...I'm waiting in the car...no radio on either...
Anybody ready to kiss and makeup?
Joan?
(Geez, I really don't know when to quit, do I?)
Lisa aka UNClear instead of CNClear
Just kidding...
Sorry, radeck and all... didn't mean to sound so condescending...i really didn't mean it as bad as it came out...shouldn't have taken my bad day out on y'all...
Sorry, rokkit, for trying to drag you in, too...
If anybody is looking for me...I'm waiting in the car...no radio on either...
Anybody ready to kiss and makeup?
Joan?
(Geez, I really don't know when to quit, do I?)
Lisa aka UNClear instead of CNClear