The IDE approval is really a big deal; it means the FDA is sufficiently satisfied with the safety and efficacy of the device enough to allow live human trials. Titan has been working with the FDA for YEARS now to ensure they will meet all necessary criteria when we file for the IDE.
The only thing I'm missing right now is a statement from management indicating the status or completion of the design tweaks, which surely are needed in advance of the filing - they can't tell the FDA "We want to use something like this but different..."
So once the IDE application is in, the design is locked down, and we are truly ROLLING! I only hope our share price will reflect that fact...
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Thanks broheim steamroller. Im not fretting, IDE submttal in Q4 is huge and if we can pull it off it will be the beginning of the beginning! Big times ahead in titanville. After all these years, things are finally materializing. Long focus on the big picture shows things are looking up.
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