FDA Pivotal-Study Feedback Receives for Alpha1H in NMIBC
“The Oncology Division at FDA has been extraordinarily helpful and collaborative, and we celebrate this latest interaction as a major step forward for the Alpha1H program, getting us closer than ever to making this therapy available to patients in the shortest time possible. We are grateful for the FDA’s support and look forward to next steps, to implement this feedback into the clinical program and begin study enrollment, says Hamlet CEO, Catharina Svanborg. The Hamlet team she has assembled includes the consultants from Target Health in the US and InClino in Europe.
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