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What are the chances of this happening with great data results? "Conditional Approval" "Commercial Marketing Approval"

Should the FDA Approve More Drugs after Phase II? A Response to Matthew Herper

Last Friday, Forbes health care editor Matt Herper and I sat down to talk about my proposal, which I detailed in a paper for the Manhattan Institute, to encourage the FDA to approve more drugs after mid-stage phase II testing, using a process called “conditional approval.” (You can read my proposal, in three parts, here.) Matt put forth some very perceptive critiques of the idea, which I respond to in today’s dispatch.

As a refresher, my proposal builds on an existing FDA procedure called accelerated approval in which the FDA approves drugs that show great promise in phase II, with the caveat that the drug sponsor must still perform confirmatory phase III studies. If the phase III studies ultimately show that the drug doesn’t work as advertised, or has previously unknown safety issues, the FDA can revoke its approval. This is exactly what happened when the FDA revoked the approval of Avastin in breast cancer, after phase III tests did not reproduce the early signal of benefit that the drug had shown in phase II studies.

The problem is that the accelerated approval process is only available to drugs for serious, life-threatening diseases like cancer. It’s not available for the common, chronic disorders, like diabetes and heart disease, that affect hundreds of millions of people. As a result, fewer and fewer companies are bothering to develop drugs for these important diseases. So I am advocating a conditional approval process, similar to the existing accelerated approval process (but with some important technical differences), that companies could use in virtually any disease area.

https://www.forbes.com/sites/aroy/2012/05/04/should-the-fda-approve-more-drugs-after-phase-ii-a-response-to-matthew-herper/#43e8dae643e8