Jul. 15 at 11:40 PM
$CAPR
I'm not criticizing the company, but if the FDA rejects the BLA, they’ll likely need to resubmit, which means approval won’t happen this year. It could be next year. This is standard for safety, regardless of the drug’s value.
Think of it like making your restaurant’s signature dish—everyone’s favorite. If a health department finds issues with sanitation or ingredients, they may warn you, shut you down, or refuse to recertify you.
From experience, if the FDA finds missing data, the company will have to redo the tests—they can’t just reuse old data. Getting the data the FDA is asking for isn’t something that can be done quickly; it could take several months and these are very expensive process. CMC may also have some issues. So, approval is unlikely this year, probably next year.
