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Posted: Wed Jun 09, 2010 6:51 pm
by Cece
I was a month out when he was canceled, so maybe I am tenth on the list? I can get there quickly too, if Dr. Sclafani starts raring through that list. :)

But DrS: if you tell us tomorrow that the IRB needs the revision and it's another month, that is disappointing, but okay.

Posted: Wed Jun 09, 2010 6:59 pm
by drsclafani
zinamaria wrote:Hello all,

Just thought to mention that there is no way Sclafani, while with Zamboni, does not have internet access...they all have computers with internet. He's most likely way to immersed to post right now.
zina
U got that rigjt sister
Its five freakin am and I am still working
Dr z asked me to present a short speech to his foundation tomorrow so I am trying to prepare something on ivus and azygous and tim. On an ornery computers

Miss yous toos
Or is it
Miss yos toes

Posted: Wed Jun 09, 2010 7:00 pm
by garyak
that is too funny - what a guy

Posted: Wed Jun 09, 2010 7:07 pm
by Cece
Hey DrS...I bet you'll rock that speech!

Maybe show them that image of the azygous with 3 valves? That one's a beauty.

(Anyone else hear the jingling of sleigh bells, as he dashed through? :) )

Posted: Wed Jun 09, 2010 7:39 pm
by girlgeek33
drsclafani wrote:
U got that rigjt sister
Its five freakin am and I am still working
Dr z asked me to present a short speech to his foundation tomorrow so I am trying to prepare something on ivus and azygous and tim. On an ornery computers

Miss yous toos
Or is it
Miss yos toes
You will rock the speech!!! So excited you are there with Dr. Zamboni. Give him LOVE from all of us!!!!!!!

I certainly hope the IRB is considerate enough of all of your anxious patients and sends you the results via email! They shouldn't make you wait until you can find the guy while in the same time zone!!! If they don't send email. Will Holly be able to find out and update everyone?

Posted: Wed Jun 09, 2010 10:08 pm
by simone
drsclafani wrote:
zinamaria wrote:Hello all,

Just thought to mention that there is no way Sclafani, while with Zamboni, does not have internet access...they all have computers with internet. He's most likely way to immersed to post right now.
zina
U got that rigjt sister
Its five freakin am and I am still working
Dr z asked me to present a short speech to his foundation tomorrow so I am trying to prepare something on ivus and azygous and tim. On an ornery computers

Miss yous toos
Or is it
Miss yos toes
Sure would be a better planet to have many more of YOUSES.
Can't wait to hear stories. discoveries. Hope you have some time to enjoy Italy and a little rest.
Sending you virtual hugges.....

Posted: Wed Jun 09, 2010 11:08 pm
by Robnl
Have a good and interesting time in Italy Doc!

Robert

Posted: Thu Jun 10, 2010 1:21 am
by Donnchadh
Dr. Scalfani:

Posted 14 of the 40 venograms taken during my liberation procedure.

Donnchadh


http://www.thisisms.com/ftopict-12139.html

Posted: Thu Jun 10, 2010 3:28 am
by drsclafani
girlgeek33 wrote:
drsclafani wrote:
U got that rigjt sister
Its five freakin am and I am still working
Dr z asked me to present a short speech to his foundation tomorrow so I am trying to prepare something on ivus and azygous and tim. On an ornery computers

Miss yous toos
Or is it
Miss yos toes
You will rock the speech!!! So excited you are there with Dr. Zamboni. Give him LOVE from all of us!!!!!!!

I certainly hope the IRB is considerate enough of all of your anxious patients and sends you the results via email! They shouldn't make you wait until you can find the guy while in the same time zone!!! If they don't send email. Will Holly be able to find out and update everyone?
I sent your love and appreciation to dr z. But more importantly I sent your enthusiastic support to him as a group. Your almost 150000 views of DrSclafani answers some questionsm. I told the funders how involved and knowledgable you are. That you know more than most doctors! . They were so moved by YOU

You have just helped the father and moved trials closer to reality in three regions of italy

YOU rock!

Posted: Thu Jun 10, 2010 3:30 am
by L
drsclafani wrote:Your almost 150000 views of DrSclafani answers some questionsm.
Should this be in the Guiness Book of Records?

Posted: Thu Jun 10, 2010 5:02 am
by girlgeek33
drsclafani wrote:
I sent your love and appreciation to dr z. But more importantly I sent your enthusiastic support to him as a group. Your almost 150000 views of DrSclafani answers some questionsm. I told the funders how involved and knowledgable you are. That you know more than most doctors! . They were so moved by YOU

You have just helped the father and moved trials closer to reality in three regions of italy

YOU rock!
You so made my morning!!! :)

FDA?

Posted: Thu Jun 10, 2010 5:49 am
by girlgeek33
Okay, I've heard of IRB and I get the process. But someone has just posted something that a hospital shut down a Doc in FL because the procedure is not FDA approved. This is the first I'm hearing that FDA is in the mix at all. Does FDA approve procedures such as this? I thought they were drugs & food. So I guess I want to understand. What happens after IRB and studies are done. Does the data collected go to the FDA? Do they decide if this is an acceptable treatment? What is the next step after a successful study?

Posted: Thu Jun 10, 2010 6:42 am
by mshusband
Could be a mis-understanding ... FDA, IRB, legal counsel ... might just be rumors and whatnot right now ...

Don't worry, this is picking up more steam by the day ... once one IRB gets through, the rest will follow because they will know what to write.

Posted: Thu Jun 10, 2010 6:49 am
by girlgeek33
mshusband wrote:Could be a mis-understanding ... FDA, IRB, legal counsel ... might just be rumors and whatnot right now ...

Don't worry, this is picking up more steam by the day ... once one IRB gets through, the rest will follow because they will know what to write.
I've been trying to find out what happens after IRB approval and study finishes. Does it just get written up in Medical Journals and become available or does one of the Health & Human Services Departments review and make a determination? I'm on the web site and can't find anything after the study is concluded, what happens next...

Posted: Thu Jun 10, 2010 7:22 am
by Cece
My understanding is that medical devices are under the FDA umbrella, so if there were a new venous stent it would need to go through the FDA process, but that angioplasty itself is an already allowed procedure and further regulatory approval is not necessary for it.

So the course of action is: perform research (under IRB approval for patient protection); publish; other people perform complementary research and publish; IRs and neurologists everywhere read the published research and change their approach based on the findings.