Perhaps they wanted her to go quietly. Will one ever really know if or why?
Experienced staff are only useful when their advice is listened to. It's inconceivable that an IDE would require a 1700 page follow-up, and still be sent back to pre-sub meeting stage! That's serious regulatory and CMO incompetence, management arrogance, or a healthy combination of both.
Should OncoSil not decide to call it a day who will fall / jump next? CMO for an oncologist with medical device experience? VP Reg for one with FDA experience? Or does the buck stop with the CEO? Either way it's highly unlikely there'll be any approval news in 2016.
Ann: OncoSil Market Update March 1, page-32
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