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GeneSoft's future hinged on FDA approval
of its new antibiotic for respiratory disease.
The FDA had already rejected the drug once. Worse yet, GeneSoft's
new team had never presented before the FDA advisory committee - or
even attended an FDA hearing.
3D Communications helped them beat the odds, working with
GeneSoft to:
- craft the overall strategy
and tactics necessary for FDA approval;
- translate the science into
key messages for presenters to communicate to the advisory
panel;
- draft presentations for both
company executives and scientists;
- determine the most likely
questions to be asked by the committee/ develop persuasive
answers;
- roll the cameras and practice
presenters for the meeting and;
- guide presenters through the
arduous revision process necessary to respond to
ongoing FDA questions and concerns.
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