Caveman Jim, This is the fast track. You should see the slow track.
If only they would tell the truth.

Back down the rabbit hole. Alice in Wonderland: one pill makes you bigger, the other pill makes you small; but the yellow ones don’t do anything at all… just ask Alice, when she’s ten feet tall…

http://neurotalk.psychcentral.com/thread39476.html

Monday, Feb. 18, 2008
Duodopa...Solvay Receives Fast Track Designation From FDA

Hey, it’s only five years ago. Besides, what’s the rush? Haste makes waste.

…drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. A Priority Review means that the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.

Year 2008: "We are very pleased that the FDA has granted levodopa/carbidopa intestinal gel Fast Track designation and believe that it will be of great assistance in our efforts to expeditiously bring a new treatment option to this important and underserved advanced-stage patient population," said Laurence Downey, M.D., president and CEO, Solvay Pharmaceuticals, Inc.

Hey Larry, how about an update… you know, we were told it would take 6 months, and now 5 years have gone by…
Oops, sorry Larry. As President of Solvay, you maybe did not foresee this:
Buy this domain
The domain solvaypharmaceuticals-us.com may be for sale by its owner!

Clinical Trials News Digest June 1, 2011
http://clinicaltrialsnewsdigest.com/...or-parkinsons/
Solvay’s Duodopa Intestinal Gel Gets FDA Fast Track Status for Parkinson’s

http://neurotalk.psychcentral.com/sh...d.php?t=151943
Have it on good authority...Duodopa has FDA approval
2011
Paula W said:
well it needs to be-finally
that's good and i hate to rain on the parade but is it covered by insurance? it's out of our price range.
we need to start checking into this. it will hold it up. It’s up to patients to be loud about this.
with stalevo at 800 + dollars a bottle you can imagine how much this is going to be monthly.
damn greedy people - the world is a big corrupt place that is on a slippery slide . a good person would not make people fight for the coverage, are there any good people to influence this coverage?
__________________
paula
"Time is not neutral for those who have pd or for those who will get it."
http://neurotalk.psychcentral.com/sh...d.php?t=151731

Debi Brooks (Fox Foundation)
Member

06-10-2011, 05:14 PM
Update on Duodopa trial
Yesterday, Abbott Laboratories announced interim data from a long-term, open-label study treating advanced PD patients with levodopa-carbidopa intestinal gel…

The study will be presented on April 25 as part of the Emerging Science program (formerly known as Late-Breaking Science) at the American Academy of Neurology’s 64th Annual Meeting in New Orleans April 21 to April 28, 2012.

From FDA website:
Import Refusal Report
• FDA
Refusal Details as Recorded in OASIS by FDA
for Refusal 336-6232878-4/5/1
Import Refusal Report

Manufacturer FEI 3008853777
Manufacturer Name Egis Hungary
Manufacturer Address line 1 1475, 10
Manufacturer Address line 2
Manufacturer's City Budapest
Manufacturer Province/State
Manufacturer Country/Area Hungary
Product Code 62JIY09
Importer's Product Description DUODOPA (LEVODOPA-CARBIDOPA) INTESTINAL GEL FOR CLINICAL TRIALS
Refusal Date 06-Feb-2012
FDA District CHI-DO
Entry/doc/line/sfx 336-6232878-4/5/1
FDA Sample Analysis No
FDA Record of Private Lab Sample Analysis No
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS 502(f)(1), 801(a)(3); MISBRANDING The article appears to lack adequate directions for use.
Refusal Details as Recorded in OASIS by FDA
for Refusal 336-6232878-4/5/1


Ahhh yes misbranding. no instructions...... for a clinical trial
scientists just did not know what to do with it right fda??"?????
Misbranding ! Hahahaha.
we are dying out here and these jerks are jerking
Happy Unity parade