Hi all,If you don‘t mind, I‘d like to share with you some...

Hi all,

If you don‘t mind, I‘d like to share with you some question on the number of patients enrolled in the ongoing two P3 trials given in the recent HY report.

Since the beginning of the P3 trials in Mar 2021, I‘d always thought each trial was targeting 990 patients.

As a source of reference:
The AR from Aug 31, 2023 saying „Both Phase 3 studies evaluate sozinibercept as a combination therapy over a 52-week treatment period, each with 990 patients“.
The presentation for the latest CR from Sep 1, 2023 saying on slide 8 „n=900“ and on slide 20 „Sample size: 330 patients per arm, 990 per study“.

Then an extremely little adjustment I really didn‘t pay any attention to at the time:
The presentation for the JPM Healthcare Conference from Jan 10, 2024 now saying on slide 7 „n=~900“ and on slide 17 still „Sample size: 330 patients per arm, 990 per study“.

And finally the big surprise, at least to me:
The latest HY report from Feb 29, 2024 saying on slide 11 / page 7 „Each trial is designed to enroll approximately 912-990 treatment naïve patients“.

912 only? 8% fewer than originally anticipated?

I am not sure what to make of it:

Is it A) to be taken positively as e.g. the BCVA of all patients in COAST (both drug arms plus the sham arm taken together) is so high that even an optimistic assumption on Eylea‘s effect (e.g. showing a 9 letter improvement which is higher than ever shown in any Eylea study) can only be explained with sozinibercept having a pretty massive impact on top?

Or is it B) dumbness of management to reduce the statistical power for no good reason?

Or is it C) something completely different that I miss here?

What are your thoughts?