Replies to post #28776 on Biotech Values

[DewDiligence]

>This pattern has been occurring frequently. Companies receive approvable letters and there is no indication from the PR whether the approvable is a Class 1 or Class 2. So the question is, are the companies not relaying the FDA's message?<

If I understand the process correctly, the FDA doesn’t have to decide whether a Complete Response Letter in response to an Approvable Letter is deemed to be Class-1 or Class-2 until the Agency evaluates the contents of the CRL.