A bit more on the FDA

@LawyerTrader : Thanks for your kind words.

What's really exciting (and it is easy for us to miss these things, mind you) is
1. that all 6 indications mentioned on Slide 14 are candidates for RAT designation and subsequent expedited approval.
In fact, the FDA started accepting applications for RAT designation on 01/19/2017 (about 3 weeks ago).
Here:
http://www.raps.org/Regulatory-Focu...ive-Therapy-Applications-for-RAT-Designation/

So this isn't a pie-in-the-sky-let's-see-how-the-regulations-play-out type situation. This is real. It's happening already.
An excerpt:

"The guidance notes four other expedited designations: “Fast Track,” which includes actions to speed up development and review, “Breakthrough Therapy,” which features intensive guidance on efficient drug development, “Accelerated Approval,” which is based on “an effect on a surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict a drug’s clinical benefit,” and “Priority Review,” which shortens the review clock from 10 months to six months. -

There is a reason why Dr. Itescu headlined Slide 14 as "Ideally Positioned for the 21st Century Cures Act Environment"
and
listed all 6 indications.

I can only imagine the nice problems Dr. Itescu now has on his hands, pursuing the RAT designations for all 6 indications.
Suddenly it has started to pour in Melbourne.

2. I have been following MESO for just less than a year but as far as I can tell (someone correct me if I am wrong), the JP Morgan conference last month was the first time Dr. Itescu dedicated one full slide detailing "Scalable Manufacturing" of medicines. Make of it what you may, but it struck me right away that he was telling the audience that Mesoblast is ready to go.

Please DYOR.