RE:enrollmentMrlucky wrote: so when is a patient considered enrolled?
Day 1 ?? Day28???? or once data is finalized
- Specifically, we added approximately 30% of our total enrollment target in the second half of 2022 alone;
from july 20(40patients)-Jan 13 10patients enrolled
total patient enrollment is 150 @30% = 45 in the second half
- We are also nearing our interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment, Baxter has the right to view the trial data, and subsequently the option to make the second milestone payment to Spectral to maintain its exclusive distribution rights.
if the above is correct wouldn't they be close to the interim 40+45+85?????
am i missing something
Close ...
40 as of July 2022
10 enrolled in second half ( not great)
total at Dec 31 = 50
150 needed for Tigris target ( to be added to 170 done under Euphrates )
90 is interim data review. So 40 more needed ( or 100 more to achieve original Tigris add on total = 150)
Some believe stoppage at 90 is possible based on:
- Extreme need
- possible statistical confirmation ( see " exceeding expectation")
- open label/ ethical reasons
Hope this helps
MM