Ocata Therapeutics Inc fka OCAT

[Dragon Lady]

Quote, "Do you have a link from the FDA about needing a "full placebo arm"?"

Well, I for one am not aware of a single drug ever approved in "modern" times (probably the last 20 yrs ) that didn't involve being tested against placebo in some form or another (it's possible I'm sure that a few may exist)? It's in the hand-out, detailed cut-sheet on every drug on the market I've ever seen- how that drug performed against a placebo to show statistical, proven efficacy. In fact, numerous articles have been written and published recently about the "problem" big pharma faces of not "beating the placebo" as being one of their most troubling problems- industry wide. Their best "Drug candidates" often can't beat the common sugar pill or a "sham" treatment.

Here are numerous links about the FDA and "placebo"- numerous links and also links about the enormous complexities and lengthy time periods faced during a new drug approval process.

Here, here is just a recent one from the enormously well funded Michael J. Fox Foundation and how one of their most promising "drug candidates" was recently sunk and flushed in Phase II for "lack of ability to outperform the ole placebo". (added in a few more links writing about the "placebo problem" that plagues the pharma/bio-tech biz, the problem being they often can't beat or prove efficacy against the placebo arm and these are some of the biggest, well funded and most experienced drug companies on planet earth)

https://nwpf.org/stay-informed/news/2009/08/placebos-one/

http://www.wired.co.uk/magazine/archive/2009/10/features/the-placebo-problem-big-pharmas-desperate-to-solve

Here is the FDA on the "new drug approval process" (daunting and long and expensive)

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

Discussion of trial design - "placebo" beibg one of the key methods IRB's consider:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126501.htm

From the FDA's own "History of the FDA and drug regulation" page:

http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm304485.htm

Quote from the FDA itself:

"Although several kinds of randomized controlled trial methodologies can be useful to researchers and regulators, ultimately, it was the randomized, double-blinded, placebo controlled experiment which became the standard by which most other experimental methods were judged, and it has often subsequently been referred to as the "gold" standard for clinical trial methodology. "

Again, I'm just not familiar with many, if any modern FDA approvals being made these days (could be wrong?) through the phase II and then much, much larger and difficult phase III in which a "placebo arm" is not required or strongly preferred to be used by the FDA review boards.

My 2 cents. No way IMO that OCAT skips a phase III on "the eye"- about as close a main line into the human brain (via the optic nerve) as one can get. If one wants to get a drug quickly into the human brain- just put it in the eye and it's there faster than one can blink. The eye is a very critical, "close to the brain/blood barrier" part of the body as far as I'm aware? I'd highly doubt the FDA is going to take anything lightly that deals with a drug process and the human "eye".