Twenty First Century Cure Act Delayed

[abcdefg]

Looks like this isnt going to get passed until the end of year. Maybe breezula aka CB 03 01 could be classified as a breakthrough drug and fast tracked somehow to come out before 2021? This act could speed up basically future male pattern baldness treatments. Do you think this delay matters or would this act speed anything up for male pattern baldness?

http://healthaffairs.org/blog/2016/...-the-21st-century-cures-act-in-a-summer-rush/

"New drugs and devices can, of course, be an improvement over existing products. And when they clearly are, FDA has established pathways to get them to market and patients as fast as possible. The agency, for example, grants more than one-third of requests from industry for “breakthrough” designation for new drugs"

 

[CopeForLife]

> mid of 2016
> still waiting for a cure in an our lifetime

 

[pegasus2]

It's too late for CB. The US has already fallen behind because of shortsighted overregulation. None of us are going to use CB when it comes out, because we'll just fly to Japan and get cured. I really don't care about anything but Replicel and RIKEN at this point. Histogen may be worth taking a trip for too if they can hurry up.

 

[hellouser]

USA and the FDA are irrelevant. I'd be surprised if anyone gives a crap about that market these days considering all the stupid bottlenecks, timelines, costs and regulation.

Japan is going to make USA and the FDA a complete joke in the coming years. Like @pegasus2 said, we'll all be flying there for Replicel or RIKEN when the time comes.

 

[Pequod]

The FDA is under-funded and backlogged for years already, I would not delay treatment waiting on any company trying to get an FDA approval. One of the companies I follow in another field just got back a response from the FDA on a drug and they told them 10 things wrong with the application. it's a nightmare to deal with them.