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VivoSage's avatar

In my previous life as an IP attorney for big biopharma, the “year lost” part makes huge sense: patent life, investor confidence, clinical momentum, and patient time are all affected.

Re: the Active Scholar cohort, yes, medical and pharmacy students may be unusually informed participants, but academic pressure can make “voluntary” complicated very quickly. What about an independent scientifically literate cohort: clinicians, retired physicians, biomedical PhDs, even (LOL) patent attorneys? We are annoying, but consent-form literate.

One last question: would later FDA/EMA reviewers treat those early human PK/safety signals as useful development intelligence, or as something that raises additional questions downstream?

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