Replies to post #26153 on US Stem Cell Inc (USRM)

[BluSkies]

Phase 3 not needed LOLzz!!

"Some regenerative medicine advocates hope the new law will make FDA more receptive to future submissions just by explicitly stating that the accelerated approval should apply to stem cell therapies."

"And though Cures stops short of explicitly removing a requirement for phase III trials, winning accelerated approval can make them unnecessary."

"between 2011 and 2015 found that only 20% relied on phase III data."

http://www.sciencemag.org/news/2016/12/under-21st-century-cures-legislation-stem-cell-advocates-expect-regulatory-shortcuts-0