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Friday, August 18, 2023 6:06:03 PM
— Yes, totally. Lack of regulatory experience and the right regulatory personnel within the team is an area of big concern and I highlighted this a few times couple of years ago. I kind of expected bad management of these contractors (loss of time and money) once Duffy left.
It’s almost always in the best interest of the contractor to milk and stretch it as much as they can! In fact, we often work with outside regulatory consultants on our applications but that’s mainly to get advice around new rulings and some new product related guidance that we do not have much experience on (for example - evolving cyber security standards around medical devices). But we keep it to a minimum because we have been there and done that. And we generally know what questions to ask! ;)
“maybe the contingency gains were LDs from the contractors not achieving timelines?”
— I don’t know because I haven’t paid attention to what they said around contingency gains.
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