Denis Katz Medical Affairs
Most organizations start with something genuinely promising a strong hypothesis, a compelling mechanism, an innovative platform. The misalignment creeps in later, as that science moves toward regulatory review. An endpoint hits statistical significance without showing meaningful clinical benefit.
https://salienceclinical.com/

Salience Clinical Consulting
The second sponsor, smaller and working in a rare neuromuscular indication, did something different. Before locking their pivotal trial design, they brought the proposed endpoint, population, and statistical plan to FDA in a Type B meeting and asked directly whether a functional outcome measure under development would be considered adequately validated in that population.
https://salienceclinical.com/

Denis Katz, MD
FDA's response wasn't what they expected: the agency had no established basis for believing that biomarker actually tracked with how patients felt or functioned day to day, and without that link, a clean p-value wasn't going to carry the program. The sponsor had generated rigorous evidence.
https://salienceclinical.com/