My guess is that the original intend was to submit a standard IDE in 2021. However the improvements in the manufacturing process needed additional testing that would have delayed the filing of a standard IDE (per the May 24 PR: Submitting the IDE after these manufacturing process enhancements were completed creates a much stronger submission with FDA and greatly reduces the risk and expense of having to do repeat testing). The FDA must have suggested the EFS IDE since it allows to run clinicals trials while these tests are being run in parallel. Given the excellent results and safety profile of Isopet in pets, the FDA is probably eager to see how Radiogel can benefit cancer patients who may have failed other therapies. IMO, approval is imminent.
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