Jun. 25 at 10:59 PM
$CPIX The parent group was informed a year ago, so not new. In any case, the parent group was vital in encouraging the FDA accelerated approval of Sarepta's drug in DMD. You can be certain that Ifetroban will be strongly supported by the parent group, as well. This could move our drug into accelerated approval. We have not seen the extended phase 2 trial results, but will shortly. Our investor opinion is that based on the 2/4/26 FDA fast tracking of drug, that Ifetroban showed compelling efficacy. The clean safety profile has been proven as thousands of patients have taken drug. This includes the 1400 patients BMS tested with Ifetroban prior to BMS donating the drug to Vanderbilt (from whom CPIX licensed the drug). At this point we are awaiting DMD extended trial data, articulation of FDA requirements and pathway for Ifetroban in DMD, Schleroderma Phase 2 results (which management said were "forthcoming" in the last earnings call).
