Replies to post #78171 on Ocata Therapeutics Inc fka OCAT

[Booski]

I am convinced.....

[Dragon Lady]

"FDA PhaseOne Completion PROVES OCAT is Real

IT PROVES IT ! "

Uh, what does to be "real" actually mean? Never heard of that as a scientific term?

Actually a very, very tiny phase 1 "proves" very little. It's the first micro step in a long, long, long process in which things are "proven" using the scientific method. Further, it's taken ACTC (OCAT) 20 yrs and over $300 MILLION in sunk capital just to complete that tiny, tiny phase I, resulting in a 5 cent stock and dilution out past 3 BILLION shares.

What does one suppose it will take now to get through the actual EXPENSIVE PARTS and most timely (as in YEARS) parts- the phase II and the mega expensive and year(s) long phase III portions (most drug/therapy costs and time are wracked up in the phase III portion, NOT the tiny phase I)

MOST drugs/therapies are going to fail, get tripped-up in the phase II, not the phase I, as "blinding" and the placebo arm comes into play, making it 100X more difficult to "prove" whatever one is trying to "claim" is their treatment or therapy.

Here is a link to a very recent problem big-pharma is facing, and it's the placebo effect, aka the common sugar pill or "sham treatment". Many, many drugs/therapies (one's that looked like a "sure thing", slam dunk "miracle" in phase I) are failing in the phase II because when up against the placebo, they can't show statistical improvements any better than the sugar pill or "sham" treatment (example would be saline water being injected into the eye, versus the stem cells).

Notice some of the "heavy hitters" that recently failed in phase II, one being a drug backed by the Michael J. Fox Foundation, aka a group with money that flows like water due to his celebrity status and fund raising abilities and connections to some of the wealthiest donors on planet earth and one that has attracted, literally, the finest scientific minds and best universities in this nation and across the world.

http://archive.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect?currentPage=all

Quoting from the article:

"Ultimately, Merck's foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.
MK-869 wasn't the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.
The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson's disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn's disease, an intestinal ailment, citing an "unusually high" response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.
It's not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late '90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time."

There's a 1000 ways to get tripped up along the way folks, this is barely out of the starting gate via just beginning a phase II. High risk and will need boat loads of money (dilution) still.

Per Lanza's own statement, it also needs a lot of time, as in years- his own statement saying 2020 to commercialize which is totally in-line with needing about 2 yrs on a phase II and then 2 to 3 yrs more on the phase III and submission time and FDA review to even get a "shot" at a possible FDA approval. It's a long road no matter how one slices it IMO.

http://www.nbcnews.com/video/cnbc/32628345

[chuckanutman]

Rumper, great post.

[farviewhill]

No RUMPER.
You're not a good student of the long history of troubled r and d biotechs, many as initially scientifically positive phase 1 sounding as Oata. Phase 2 and 3 and the FDA,not to mention the needed millions, are HUGE hurdles to deal with.
I'm talking investment assessment smarts here, but to each his own fantasy worlds.

[mfirth555]

Best Post I've seen on two boards... and I totally agree..lol Merry Christmas....