RE:TranscriptFrom the transcript, Jan states:
"We're carefully considering the FDA's comments on the Trilogy 1 data, and we will continue to conduct further post-hoc analysis based on their feedback. We are also now working to finalize the statistical analysis plan for Trilogy 2, which we plan to submit to the FDA by the end of July".
Can somebody please explain to me what is going on here because this was also noted in the PR from this morning.
1) Is Jan not listening to what the FDA is saying i.e. that ACST cannot change the statistical analysis plan?
2) Or is the FDA leaving this door open?
I don't get it! Somebody please explain...