"Please spare me your prodigiously lengthy dissertations that don't address what I actually said."Perhaps you should read what you wrote first, then we wouldn't be in this position:
"I asked him if he'd prefer to take the risk of going in a trial where he could be given placebo as opposed to being prescribed an FDA approved, very efficacious, funded, KOL- recommended agent (the subject of the discussion being Ryoncil for aGvHD)."
Fact: it is placebo PLUS SOC
Fact: there is no FDA approved first line therapy
Observation and not a fact: APPEARS TO BE very efficiaous in a subpopulation of children (since you are referring to Ryoncil), real-life data in adults looks a bit different:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8417106/Once there is a well understood therapy, one for which the MOA can be explained etc. (you know what the issues were/are /
https://hotcopper.com.au/threads/ann-submits-new-information-to-fda-ind-file-for-sr-agvhd.6995803/page-237?post_id=64033845), different story, then I would agree that the trial with placebo PLUS SOC is going to be difficult to find patients.
As far as I understand - despite many claiming otherwise - a BLA for children with SR-aGVHD has not been resubmitted, has it?
I trust you can spot a difference or two when comparing the above sentence with my first reply.
Once submitted, how long will it take to be approved?
What are the timelines?
Before or after CYP-001 has been given to patients in order for your so-called "risk" to be considered anything other than an unnecessary comment?
I will stop my prodigiously lengthy disserations here. I take it that by now half way up the stairs the meaning of the words I'm addressing have already changed, just so that they can be misunderstood yet again.
(20min delay)