Oct. 17 at 5:52 PM
$RCKT They're Not Just Hoping the CMC Issues Are Fixed. They're Showing Us.
For anyone still haunted by the old manufacturing (CMC) failure, it's time to look at the new evidence, not the old ghosts. The company is dropping clear signals they've solved the problem.
Clue #1: The CEO's Language. On the last earnings call, the CEO didn't give vague promises. He gave specifics: they submitted "comprehensive analytical data" from "multiple production batches." That's the language of a solved problem, not wishful thinking. 🎯
Clue #2: The A-List Hire. In May, they brought in Dr. Priti Hegde as Chief Scientific Officer. Her resume? Genentech. You don't bring in that level of talent unless you are dead serious about quality control and building a fortress.
Bottom line: The risk isn't gone, but the breadcrumbs lead to one conclusion: RCKT has systematically addressed the CRL. They're not the same company that got rejected. The focus is now on the March 28 PDUFA.
