US Stem Cell Inc (USRM)

[Dragon Lady]

Quote LOL, "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.""

Oh gawd...the DIS-INFORMATION continues, LOL !!

Accelerated approval based on WHAT EXACTLY?

They got 20 patients they completed in the MARVEL trial. THAT'S IT. They never finished enrolling a damn phase II/III or pivotal (approx 130 more patients needed). If one thinks the damn FDA is gonna approve a major heart treatment, one that had 6 PATIENT DEATHS and 18 serious "irregular heart" beat "serious adverse events" reported, based on a sample size of 20 in their 2010, LAST TRIAL, the MARVEL trial which was SUSPENDED IN 2010 for LACK OF FUNDING, well, GOOD FREAKING LUCK WITH THAT.

FURTHER, Myocell is no longer even protected under patent per their own DAMN SEC filings and they were never able to attract any funding for it post 2010...GEE WHY WOULD THAT BE????? WHY DID THE "smart money" in the biggest bull market in world history, ALL THE SMART MONEY panned and punted on ole "MYOCELL"??? WHY?

AND, they now LACK KEY LICENSES they need to even make/use what they call "Myocell" as those all LAPSED per their own SEC FILINGS.

So what the hell is this fantasy product they're supposedly gonna submit to the FDA for a fantasy "APPROVAL"????

The stupid "CURES ACT" is NOT some magic panacea pill and get out of jail free card, that's just gonna allow companies to skip ROBUST, DATA RICH, HIGH QUALITY and STATISTICALLY proven, scientifically sound clinical trials. NOT what the "act" says or means.

They got NOTHING at this point even remotely close to being an FDA APPROVED DAMN PRODUCT and they've never, ever, ever stated so in a SEC filing, a PR or any other public statement.

Just hyping to keep the PUMP alive, but it ain't working anymore.