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Monday, March 12, 2007 11:47:20 PM
Agree, agree, agree.
This is the one indication with the most research data via IGF-1. Phase III completed, waiting for results. IGF-1 given at doseage 0.05-0.10 which is half what Iplex has shown in numerous other trials to be safe. I still maintain ALS changed the landscape for Insmed and could have been a driving factor in Insmed giving up short stature and making the deal.
I do not know all the roadblocks that may be encountered but I believe it has to be possible. ALS is way ahead of MMD or HARS and if a deal can be worked out for worldwide sales, it will save Insmed and a lot of lives. Lets hope and pray for everyone concerned that Iplex is an effective treatment, fast tracked and available soon with insurance coverage. ALS foundation has to be getting pressure to explore Iplex in a different light than IGF-1. So many things are pointing in this direction and Italy is making others get off the pot. I have had this feeling since January and movement is starting to become evident.
Some here understand the FDA process very well and perhaps could give some timeframes based on what is known and if the Mayo trial shows the same efficacy as previous US trial. Also who ownes US IGF-1 ALS patent. If Cephalon has undisputed use patents it could simplify things. Just dreaming here I guess but it is a good dream especially for those suffering with ALS and good does win sometimes.
Rod
Never argue with a fool, for after awhile, it becomes difficult to determine which is the fool.
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