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Most people, I'm afraid, are not truly aware of what the PR meant. With drugs, and I'm not sure with devices, after the drug gets FDA Investigational Drug Application approved, the proceed to Phase I testing of 20-100 patients, lasting several months, of which 70% are successfully tested. Then Phase II begins, which includes several hundred patients, lasts several months to 2 years, of which 33% are successfully tested. Then Phase II begins, of several hundred to several thousand patients, lasting 1-4 years, of which 25-30 percent are successfully tested. On average, 20 of 100 drugs granted investigational drug application approval will be approved for marketing. This is straight from an FDA chart. Go to www.fda.gov to check for devices. |
