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Old 10-29-2014, 05:37 PM
zanpar321 zanpar321 is offline
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Join Date: Feb 2014
Posts: 365
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zanpar321 zanpar321 is offline
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Join Date: Feb 2014
Posts: 365
10 yr Member
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Quote:
Originally Posted by Tupelo3 View Post
We've spoken about NeuroDerm and their continuous, subcutaneously-delivered liquid LD/CD product, ND0612, on several different threads recently. So, I figured I would just start this thread with their announcement of Phase Ii results. Not surprisingly, they were great and the company will continue moving forward with more trials that are required for eventual FDA approval.

This was, however, a good news bad news story. The good news was the very positive results with little, if any, side effects (as opposed to Abbvie's Duodopa gel and pump surgery). The bad news is that the company estimates that if everything goes according to plan, the pump and liquid LD/CD will be available for general use in 2018. It just seems to me to be outrageous that it should take so long to test and get an approval for a liquid formulation of a drug that has been available on the market for over 40 years and a basic insulin pump which are used everyday by diabetics. NeuroDerm received their first MJFF grant in 2010. So 8 years to approval, if everything goes right.....hmmmmm, doesn't seem right to me.

Gary

http://www.prnewswire.com/news-relea...280818122.html
It takes big bucks to pay to play with the FDA.
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"Thanks for this!" says:
Betsy859 (10-29-2014)