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Posted by Alexander on 23:19:50 2004/08/03
In Reply to: Re: Encapsulation posted by karl
With respect to clinical trials of a technology which has been proven to work well in a variety of animals -- estimates for full scale Phase I, II and III clinical trials may increase from $5 to $100 million per year for 5 - 7 years before routine islet cell therapy might be available.
Costs could be lower if one could gain approval for orphan drug trial rules -- but diabetes is so widespread the minimal ophan rules do not apply.
Another route would be to do the human studies abroad -- for example in India or Pakistan -- where new medical devices and treatnents would not be delayed by overly strict US regulations.
Of course, one would have to select the "right" islet cell therapy -- which would pass testing -- or you start all over again from ground zero.
Contrasted with billions effecrively shot over the border to conquer third world countries -- while I may be biased -- I believe diverting a few hundred million dollars to candidate islet cell therapy trials for diabetes & a few other costly chronic conditions -- would be a better investment of government taxes and resources.
Unfortunately, the current administration wants private capital to pay for R&D on new therapies and drug companies prefer to avoid investing in one shot treatments which cure disorders -- and tend to invest in therapies which require long term treatment with expensive pharmaceuticals.
This is how drug companies make a large profit.
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