Ocata Therapeutics Inc fka OCAT

[Dragon Lady]

LOL Quote, "-FDA decision (I don't foresee this needing a phase III)"

Well, not sure the ole FDA is gonna see it that way? A few steps left out of that "list" IMO? Like about 2 yrs minimum on the phase II, getting past an actual phase II with an approval- most drugs that fail, they fail in the phase II portion- as it's much larger and much more stringent than a tiny, 18 person phase I. Also, it's not even clear yet if this OCAT phase II will be blinded and have a full placebo arm? If not then that has to occur at some point also or the FDA won't even consider the drug or look at it IMO.

Then there's a very large phase III, at least one at a minimum and sometimes even more than one needed if the FDA isn't convinced of the data presented in the first phase II/III trial cycle- which is a minimum of probably 5 yrs away which is exactly the time frame Lanza himself said.

Long, hard and very expensive road ahead. The "list" was missing about 500 or more steps IMO. It's a lot tougher for a drug approval that 1,2, 3 stamp it and sell it and an imaginary "lets just skip phase III" cause well, it sounds like a good idea. Again, not a chance in heck IMO the FDA would ever see it that way.

Year 2020 per Lanza's own words (and a dump truck full of cash along the way he didn't even mention- cash they presently do not have):

http://www.telegram.com/article/20141014/NEWS/310149525&Template=printart

Quoting that local, MA newspaper journalist speaking direct to Lanze:

"New medical treatments generally must undergo three phases of human study to demonstrate safety, proper dosing and efficacy before the Food and Drug Administration will approve them for sale. In addition to its phase 1 study in the United States, Advanced Cell has been conducting a phase 1 study of its RPE cells in patients in the United Kingdom.

"We treated the last UK patients last month, and they also have not seen any safety issues related to the transplanted tissues themselves, either," Dr. Lanza said.

Advanced Cell now hopes to launch a 100-patient, phase 2 study in Stargardt's patients by the end of the year, according to Dr. Lanza.

A second, smaller phase 2 study in patients with age-related macular degeneration would follow, he said. Any treatment might not be ready for FDA approval until 2020, Dr. Lanza said. "

Well, that was dated Oct of 2014 so they didn't even make the "hopes to" and by the "end of the year" part for starters.

Lanza also clearly stated, "ANY treatment" and then the word "MIGHT not be ready" - very carefully phrased IMO. So 2020 isn't even a sure thing- which of course makes common sense. A 100 ways to get tripped up by the FDA or other issues along the way in a phase II. It's always that way with new drug R&D. Nothing's a slam dunk, sure-think here by a long, long, long shot here IMO. No way. Not even finished a phase II yet. They're barely out of the starting gate into a long, difficult gauntlet known as the FDA process.