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Thursday, March 22, 2007 1:32:49 AM
Posted by: Cee-It
In reply to: THE LURKER who wrote msg# 1600 Date: 2/22/2007 3:23:16 PM
Post #
I'm not employed in this field, but I've traded in this field for more than ten years. While there is no fixed timeframe, because each case is unique, it seems to take about 3 to 5 years to go through all three clinicals and get approval (or rejection).... sometimes MUCH longer. The FDA has been working at shortening that timeframe for urgent areas, but there is a lot of rigor required and short-cuts increase the risk of error significantly.
I wouldn't worry too much about the time frame. When word gets out about how good the technology is they will likely become a take-over candidate. At that point the PPS could shoot through the roof especially if two companies are competing for us. My guess is when Phase I is finished everyone will have a good idea where this is going. Hopefully within four to ten months.
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