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Re: LegendaryNomad23 post# 176777

Tuesday, 07/09/2024 12:27:02 PM

Tuesday, July 09, 2024 12:27:02 PM

Post# of 178689
My thoughts are to wonder how the RDGL device is being treated by the FDA?

In other words Brachytherapy is not some new device... it has a decades long history.
Y90 is not a new radioisotope for cancer treatment... it has a long history as well.

The gel is an original formulation and the Y90 is far more pure than currently approved bead brachytherapy solutions.

Is FDA approving this as a new device? A new formulation for an already approved device? A human safety improvement from category 3 to 2 (more safe) for an existing device use justified by the Breakthrough Device Designation?

The answers could significantly affect/shorten the typical timeline here, no?

Discuss /explain if anyone here is up on all that stuff please?

- Go $RDGL
Bullish
Bullish


All imho offered freely. Understand you should not take my advice in lieu of doing your own work to invest suitable to you. The cape doesn't give me super powers IRL.

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