Morning all -
On the topic of disclosure of patient deaths, it would be highly unusual for the company to provide an immediate update when a trial patient succums to their MND. Without wanting to sound crass, the disease is invariably fatal, so unless the trial drug was implicated in the cause of death, it's not likely to be material information.
What is likely to be material is the periodic analysis conducted by Berry, which will be updated to reflect patient deaths, ALSFRS-R scores, etc. We've been told that this will be updated each quarter.
Unfortunately, patients with terminal diseases pass away while on clinical trials. These events are not generally reported in real time - the company isn't adopting a novel approach here.
Think back to the canine trial - same approach. Canine trial subjects died from their lymphoma and there were no real-time updates. This is normal.
Reporting individual events risks over-amplifying their significance - whether the event is positive or negative. It is a much better approach to provide a complete, updated statistical analysis.
There's some useful guidane for life science companies managing their disclosure obligaitons provided by the ASX here:
https://www.asx.com.au/documents/research/Code_of_Best_Practice_for_Reporting_by_Life_Science_Companies.pdf
The key takeout for us in the current context is that an individual patient death is not likely to be the material information, it's what that event does to the survival analysis that matters.
Cheers
Densy
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