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One week: Dramatically reduced market timeline and regulatory uncertainty
A late stage startup received a “Refuse to Accept” letter from FDA.
VP of Product R&D was in an “existential crisis” and needed to determine how to respond to FDA so that the submission would be accepted and the review clock started. There were only two weeks to find consulting support and execute the turnaround. He needed to preserve the regulatory timeline; investors wanted to know.
I organized regulatory coaching and security review, using a panel of expert advisors and facilitating an asynchronous rapid Q&A process. We answered all of the company’s questions within 24 hours, met several times to ensure the responses were sufficient for the VP to take action, and stayed on board until the company resubmitted to the FDA.
The new submission was accepted. The VP felt “huge relief” during the process, and his confidence in getting to market drastically increased.