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(11,841 posts)A big killer worldwide. A company now called Navidea was developing a drugs called RIGS. It would mark all cancerous tissue so that nothing would be left behind in surgery. They did trials in the 90s when they were called Neoprobe. All the trials were successful and no side effects, but the FDA decided they needed "more information". Well, Neoprobe ran out of money. Meanwhile, as the years passed, 70% of the people who had used RIGS were still alive, compared to 20% of those who didnt. Neoprobe became Navidea and finally got some cash, finished deveoping another cancer diagnostic, Lymphoseek, which is better and safer at finding cancerous lymph nodes in breast cancer patients, as well as other cancers. They got approval for that earlier this year.
RIGS, meanwhile, stayed on the sideline because the FDA wanted trials to start all over again instead of continuing where they left off. How many people could possibly still be alive with the earlier success rate? Who knows.
But why would the FDA insist on new trials when this is a diagnostic used once? the safety would likely be fine since its not something taken continuously
The company hopes to restart the program sometime in the future.