Replies to post #44334 on Biotech Values

[gofishmarko]

>> Your argument ought to be directed to Congress rather than the FDA. <<

A new law that provides for Accelerated Approval based on marginally sub-standard survival data , with provisions for confirmation before full approval , would make sense.

However , there is no need for such a law now for the FDA to apply the logic to drugs like DNDN. They just have to grasp the logic. Maybe it will take a new law for them to do that.

Clearly they have the authority to approve DNDN with conditions regarding completion of 02B. They just don't have an easy way to explain it when they do , and other companies will rightly wonder WTF FDA policy really is.