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Re: bjw5364 post# 176362

Friday, 06/28/2024 8:02:58 PM

Friday, June 28, 2024 8:02:58 PM

Post# of 177068
Updating with info from 10K

The Company intends to apply for a de novo petition with an anticipated expenditure of $10.0 million over the next four years. This expenditure estimate includes anticipated costs associated with in vitro and in vivo pre-clinical testing, our application for an Investigational Device Exemption, Phase I and Phase II clinical trials and our application for a de novo petition.



So maybe plan is
- IDE approved in next 30 days,
- Mayo Clinic approves their clinical trial plan.
- IDE Clinical trial completes in 6 months to a year,
- conduct phase I and Phase II clinical trials and our application for a de novo petition over 2.5 to 3 years
- file application for de novo petition.
- routine radiogel treatment begins
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  • 1Y
  • 5Y
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