'Another complicating factor was that Oncosil’s application marked the first time anadvisory body called the Clinical Oversight Committee was involved in the approvalprocess for an active implantable medical device.'
http://www.biotechdaily.com.au/media/Dr%20Boreham/OSL%20May%2024%202019.pdf
Interesting how Oncosil made absolutely no reference to the Committee, or the fact that it was the first time being used for such an approval, in any previous investor briefings or other comms. I still believe (although I'm no lawyer) the laguage of "extremely confident" and "imminent" and the non-mention of the oversight committee is potentially grounds for class action on the grounds that full and continuous disclosure was not maintained...
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