now wasn't that more fun than just getting other people to justify to you?
Oh, if the person who passed away was not on trial, the company has no right to know anything - which is why the OLE trial exists.
They have no right to know anything about the patient. As for when, well, it can't be all that long ago but i don't know when the company was told.
As the person was NOT on any trial and the company would not know what they did in the lead up to their passing away, I can see why they are saying it is not material - but all the same, not a great way to communicate it in the 4C. I concede that point.
The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-1225
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