The COVID-19 ARDS phase 3 trial won't be impacted by the alleged JCR manufacturing problem for TEMCELL in Japan (the only reference I've seen is in @Anjo-Roch post https://hotcopper.com.au/threads/bp-update-fri-5th-june-2020.5434132/?post_id=45076312).
JCR manufactures their own version of remestemcel-L/Ryoncil, and that is what is approved for use in Japan. MSB's Ryoncil probably couldn't be swapped in easily, since it hasn't been approved in Japan. Presumably JCR could test for equivalence and maybe get it approved, but that would take time. Could be a source of even earlier sales for MSB if this could be arranged?
But highly unlikely to happen, MSB will surely prioritise inventory for the committed trial.
I did do a bit of a search to see if I could verify this alleged manufacturing issue and couldn't find any references at all. Would be interested to know more if any of our better investigators wanted to get on it.
The COVID-19 ARDS phase 3 trial won't be impacted by the alleged...
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