Parkinson's Disease Tulip


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Old 03-19-2013, 07:33 PM #1
Jim091866 Jim091866 is offline
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Bumping it up



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Originally Posted by Jim091866 View Post
All you have to do is substitute an "E" for the "P" in PD and we'll have approval!
Just imagine reduction in off time of an average of 4 hours. More "on" time, oh yeah! Bob tell me we wouldn't see a record Fast track there!

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Old 03-20-2013, 01:13 AM #2
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Conductor71 Conductor71 is offline
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Quote:
Originally Posted by Jim091866 View Post
All you have to do is substitute an "E" for the "P" in PD and we'll have approval!
Just imagine reduction in off time of an average of 4 hours. More "on" time, oh yeah! Bob tell me we wouldn't see a record Fast track there!

Ha ha ha. It would be funny if it were not so pathetically the case.

Jim, as for old information, I did make a mistake on the AAN announcement. We see what we want to see, and my eyes being the window to the soul, I saw 2013 leap out when it in actuality was last year 2012. I wanted it to be so, and my brain played right along. Funny, how the power of suggestion and cognitive decline do not mix so well. So sorry about the confusion. Had I not been to lazy to link a source, I would have avoided it.

That was really of less importance than Abbvie being the lead sponsor of the Unity Walk, but I feel bad for misinforming others. There is no way Abbvie would position themselves as a major presence supporting PWP if they have no treatment to offer us. As Bob stresses it would be weird for them to sponsor that but offer us nothing more than we plan to submit for FDA approval this month, but who knows all is possible in this vaudeville act put on by the FDA. Timing an announcement with the Unity Walk gets them name recognition and great press; is is crucial for them to market directly to us because doctors only want to talk brain surgery. Many PWP are not even aware of this stuff.
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Old 03-20-2013, 01:51 AM #3
Bob Dawson Bob Dawson is offline
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Well, Conductor 71, here is some 2013 news about the sponsor of this year’s Parkinson’s Unity Walk at the end of Parkinson’s Awareness monrth:

AbbVie Opposes Disclosure of Studies on its $9.3 Billion Humira
by Ed Silverman March 11, 2013

In a direct challenge to the proponents of disclosing clinical trial data, AbbVie has filed a request for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies concerning its top-selling Humira rheumatoid arthritis treatment, The Financial Times writes.

The filing comes after two Freedom of Information requests were made to the EM last year to release “raw data” on the safety and efficacy of the medication, a ten billion-dollar seller…

Also. ….Last year, Abbott Laboratories which has since spun off AbbVie, filed a citizen’s petition with the FDA to ask that the agency not approve any biosimilar for its Humira treatment for rheumatoid arthritis….

The latest move comes amid a heated controversy over data disclosure…. researchers who argue that results cannot be independently verified unless patient-level data and case-study reports are fully disclosed.
There are, however, cracks showing in the stance taken by the pharmaceutical industry. Last year, GlaxoSmithKline agreed to make patient-level data to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data. However, the drugmaker has not yet launched its effort…
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Old 03-21-2013, 07:50 AM #4
Jim091866 Jim091866 is offline
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Default No need to apologize

Conductor71, no need to apologize. I was simply lost with where did this come from when I read your post. I'd like to think I'm up to speed (ha) with what is going on in the realm of parkinson's but maybe not. The statement that not many PWP are aware of this therapy is an understatement. In the past 6 months or so I have been hospitalized 3x for various reasons. They have always had a neurological consult done just to ensure that I am ok. NONE of these neurologists had any idea of what I was talking about and one even said "So what is the big deal, you have to have an operation to have a tube put in that has to be maintained. Why not just take the pills by mouth." I kid you not!





Quote:
Originally Posted by Conductor71 View Post
Ha ha ha. It would be funny if it were not so pathetically the case.

Jim, as for old information, I did make a mistake on the AAN announcement. We see what we want to see, and my eyes being the window to the soul, I saw 2013 leap out when it in actuality was last year 2012. I wanted it to be so, and my brain played right along. Funny, how the power of suggestion and cognitive decline do not mix so well. So sorry about the confusion. Had I not been to lazy to link a source, I would have avoided it.

That was really of less importance than Abbvie being the lead sponsor of the Unity Walk, but I feel bad for misinforming others. There is no way Abbvie would position themselves as a major presence supporting PWP if they have no treatment to offer us. As Bob stresses it would be weird for them to sponsor that but offer us nothing more than we plan to submit for FDA approval this month, but who knows all is possible in this vaudeville act put on by the FDA. Timing an announcement with the Unity Walk gets them name recognition and great press; is is crucial for them to market directly to us because doctors only want to talk brain surgery. Many PWP are not even aware of this stuff.
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