"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.
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