RE:RE:RE:RE:Volume Right. Patient 25 should reach 450 days sometime between Thursday, Nov. 24, 2022 and Saturday, Dec. 24 2022 depending on when in September 2021 he/she was first treated. According to the last MD&A:
"The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessments for 25 patients, expected in 4Q2022, subject to the CSS’s ability to complete all required assessments."
Once the BTD application has been made - likely before the end of December - the FDA will have 60 days to respond with a yea or nay. If all goes well we should have BTD in March 2023. (God willing)
stocksnbonds458 wrote: Aren't we putting the BTD cart before the horse? I was under the impression we apply (officially) for BTD in December, then with the grace of God get said designation first quarter 2023.