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SC8

Re: S ceeate post# 163053

Wednesday, 07/12/2023 3:12:36 PM

Wednesday, July 12, 2023 3:12:36 PM

Post# of 180558
Wrong. Here's the quote: "Next week we will submit the protocol to the FDA for review at a Pre-Sub meeting as they recommended. In addition we will request a review of our comprehensive Risk Management report, which concludes that RadioGel™ is intrinsically safe.".

That only confirms a forecast submission this week, not a meeting this week.

We've been through this four times now before this. Submissions are made with a meeting request to get on the review docket. Then one waits to hear back with meeting date from FDA. But one doesn't actually want the meeting. Upon review of submission, FDA will cancel meeting if nothing is flagged in review requiring a meeting discussion.
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