DNAprint Genomics (DNAG)

[frogdreaming]

It was a rhetorical question. lol

It costs an average of $900 Million to develop a new drug. It is obviously 'more profitable' to reincarnate previously developed drugs than to start over with new drugs.

You are correct, the guidance hasn't prevented anyone from developing classifiers, and all those classifiers are just waiting for the 'forms' and the rules for the approval process.

The 'reason' the FDA is developing the guidelines is that the industry has a number of products developed that they want to move forward on, but they can't go anywhere until the templates have been designed and the appropriate designators have been standardized and the approval process has been released.