I meant risk management plan in the essence of what it is, which is a plan to manage risk.
The only risk I can see with GTCB is that the underlying production platform is new, and there is potential for people to talk about goat genes invading humans etc. That wording probably sounds stupid, but there are people who feel rather passionately about such things and will probably say it in much smarter ways.
Effectively it is headline risk, and I can see an advisory panel giving cover to the FDA from such risk. Perhaps the plan and its implementation itself will be trivial, more in the nature of supervising the goat farms and preventing contamination etc.
I still think an advisory panel is more positive than negative because of the strong data. I would think the opposite if data were weak because the usual setup for the FDA has been to murder biotechs with weak data using advisory panels.
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