Replies to post #6367 on US Stem Cell Inc (USRM)

[Gsdubb]

The MIRROR trial mirrors the FDA approved trial protocols of the Marvel trial. The only difference is the Myocath being used instead of the J&J Myostar. The Myocath as an enhanced deflective tip which allows for more accurate cell placement. As long as the guidelines are followed, the BLA panel will review and give approval if the results are as good and safe as anticipated.
This is where I read about some of the trials being in Mexico to reduce costs:

http://www.firstwordpharma.com/node/1066758?tsid=17#axzz2wvepoe4G

This was of course regarding Angel, but there is a general statement of oUS trials to reduce cost. Given the limited funds, they are going about the most optimal path.

As far as journals go, I don't believe it is a requirement to be registered. I will have to look into that.

[mdub]

Because it is a waste of time and resources? The FDA is a joke. In case you thought otherwise, a warning about high dose tylenol was put out a few weeks ago. Its been around for 60 years. Also, advil wouldn't be approved if it were being brought up today. So...theres a short lil bit about the FDA. Finally, no. You absolutely do not need to register your trial with the FDA to get published.