Replies to post #78410 on Ocata Therapeutics Inc fka OCAT

[Dragon Lady]

"This will sail through the FDA procedures,
because it's not a drug. "

"THIS IS NOT A DRUG.

THIS IS TISSUE REPLACEMENT. " ???? What? NO. Not even close. What facts is this assertion based on? Where is this disclosed in OCAT SEC filings or similar?

Again, NO. It's VERY MUCH A DRUG according to the U.S. FDA and according to the FDA "DRUG" trial(s) approval and submission path that OCAT is pursuing. WHY would OCAT be out trying to raise $60 million to $100 MILLION dollars in pure, Grade-A DILUTION money to run FDA TRIALS, seeking FDA APPROVAL is this was "imaginary" gonna just "fly through" cause it's supposedly "not a drug" and practically like putting a band-aid on one's finger?? Makes ZERO sense.

There has even been several Federal court cases now and the FDA has prevailed each time, that STEM CELLS ARE DRUGS and to be regulated AS DRUGS.

From the FDA WARNING TO CONSUMERS regarding stem cells:

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

"FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system"

"Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products."

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm

http://www.nature.com/news/fda-s-claims-over-stem-cells-upheld-1.11082

"FDA’s claims over stem cells upheld
Drug watchdog wins right to regulate controversial therapies."

" The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient’s own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs."

http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/

"Judges Side with FDA on Stem Cells
A US federal appeals court maintains that stem cells proliferated in a lab must be regulated as a drug.

By Kerry Grens | February 6, 2014"

"The D.C. Circuit Court of Appeals ruled this week (February 4) that culturing a patient’s stem cells for therapeutic use falls under the aegis of the US Food and Drug Administration (FDA). FDA has said therapeutic stem cells should be regulated as drugs."

It's CRYSTAL CLEAR that OCAT's "product(s)" that DO NOT YET EXIST and are not YET COMMERCIALIZED, "IF" they ever do come to market- are going to be 100% regulated as "drugs". Simple as that.

OCAT isn't "sailing through" anything. They've been at this 20 (TWENTY) yrs now and just completed a tiny, tiny phase I trial. Per their own statements- they have at least 5 more yrs and $100 of millions of dollars needed for a "chance" at a commercial, FDA approved, salable, commercialized, proven safe w/ proven efficacy for use in humans, product/therapy.