The coordinator reads the letter again. Hepatotoxicity is new. It was not in the previous IB edition. The study has 14 currently enrolled participants, three of whom reported mildly elevated transaminases at their last study visit -- events that were documented, graded, and reported to the sponsor as unexpected findings because the prior IB did not list hepatotoxicity as a known reaction.

That word -- "unexpected" -- is about to change. With this IB amendment, hepatotoxicity is now a recognized adverse reaction of the investigational product. Future transaminase elevations may be classified differently. But there is more: every currently enrolled participant signed a consent form that does not mention liver injury as a risk. And the study's monitoring plan does not include the hepatic function panels that the new safety profile would warrant.

This is not a document to file. This is a document to act on.

The coordinator reads the letter again. Hepatotoxicity is new. It was not in the previous IB edition. The study has 14 currently enrolled participants, three of whom reported mildly elevated transaminases at their last study visit -- events that were documented, graded, and reported to the sponsor as unexpected findings because the prior IB did not list hepatotoxicity as a known reaction.

That word -- "unexpected" -- is about to change. With this IB amendment, hepatotoxicity is now a recognized adverse reaction of the investigational product. Future transaminase elevations may be classified differently. But there is more: every currently enrolled participant signed a consent form that does not mention liver injury as a risk. And the study's monitoring plan does not include the hepatic function panels that the new safety profile would warrant.

This is not a document to file. This is a document to act on.