The best reassuring news:
❖ Revised the Instructions For Use to further simplify theguidance for application✔️
❖ Updated bottle label and carton to prominently display“wash hands with soap and water immediately after use”✔️
❖ Conducted a pilot human factors study to demonstrate therevised Instructions For Use are reliably followed✔️
❖ Filed an end-of-review meeting request with FDA to be heldend of November/start of December CY 2023 ✔️
BOT has hit the ground running; very nice to see.
I foresee that the meeting with FDA will no longer be a steering meeting, but instead be 'hey, we've actioned your feedback, we have initial proof that the action is sufficient to your needs (via the pilot HF study); what more do you want?".
Ann: Investor Presentation and Investor Meetings, page-2
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