Replies to post #28824 on Biotech Values

[DewDiligence]

Class-1 vs Class-2 Complete Response Letter (CRL):

>We have spoken with other management teams where the classification was provided to them up front. It appears to be variable, but the question always needs to be asked in these situations.<

Technically, it is the sponsor’s CRL—not the FDA’s own letter—that the FDA designates as either Class-1 or Class-2. However, in some cases, the nature of the FDA’s concerns may be such that it is obvious which class the sponsor’s CLR will fall into before the CRL is actually submitted.

What makes a CRL Class-1 vs Class-2? The supposed standard is that clarifications and finer granularity on existing data are designated Class-1 and CRLs that contain bona fide new data are Class-2. However, in practice, the Class-1 vs Class-2 distinction is whatever the FDA says it is!

The PDUFA guidelines specify that the FDA should reply to a Class-1 CRL within two months 90% of the time and should reply to a Class-2 CRL with six months 90% of the time. Regards, Dew