Ocata Therapeutics Inc fka OCAT

[Dragon Lady]

HIGH_RESOLUTION_REALITY of the extreme COSTS and DIFFICULTY to reach a FDA phase III completion, let alone an approval.

http://www.manhattan-institute.org/html/fda_05.htm

Manhattan Institute- highly credible, respected research firm. Not some penny stock "review" newsletter or something.

"Part 1: Phase III Trials Are driving Rising Costs in Medical Innovation

In 1975, the pharmaceuticals industry spent the equivalent of $100 million in today’s dollars for research and development of the average drug approved by the U.S. Food and Drug Administration, according to the Tufts Center for the Study of Drug Development. By 1987, that figure had tripled, to $300 million. By 2005, this figure had more than quadrupled, to $1.3 billion"

http://www.fiercebiotech.com/topics/fda_approval_process.asp

"In order for pharmaceutical and biotech companies to market their drugs and biologics, companies must receive FDA approval, a rigorous, expensive, and time consuming process that can take over a decade to complete. Of 5000 compounds discovered in the pre-clinical stage, only about 5 will make it through the entire FDA approval process. Therefore, companies have to cover not only the cost of successful development of a single drug, but of many drugs that never make it to market."

FORBES, one of the most credible, biz journalistic sources still in existence:

http://www.forbes.com/sites/theapothecary/2012/04/25/how-the-fda-stifles-new-cures-part-ii-90-of-clinical-trial-costs-are-incurred-in-phase-iii/

"90% of Clinical Trial Costs are Incurred in Phase III"

http://www.raps.org/focus-online/news/news-article-view/article/1359/report-phase-iii-clinical-trials-behind-increase-in-the-cost-of-pharmaceuticals.aspx

http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm

What does a phase III FDA submission look like? Think it's a few forms being filled out and a little ole power point presentation being tossed in with some nice color slides attached to it?

A phase III FDA submission is typically 1000's of pages, even 10 THOUSAND pages of documentation- it's a mind boggling undertaking. There are entire contract firms, or in big pharma, entire dedicated departments with 100 or more people in them, all degreed specialists (from Ph.d's to M.D.'s to Masters in pharma and chem and science and engineering and bio-med and similar fields and full time tech writers, etc) doing nothing but FDA submission and regulatory affairs who may work a yr or more as a focused team just to write and draft the submission package. They then must do a long series of back-n-forth question and answer formal question/answer submissions and all done per very specific protocols, in reply to anything the FDA wants to ask or know or have clarified. DAUNTING, complex and labor intensive and time consuming and MEGA EXPENSIVE.

The photo is from the FDA site itself, in the link above. Think this is a "slam dunk" and "done deal" cause they completed a tiny phase I and put some cool looking color slides together in a 20 page presentation or whatever??



Photo title: Chemist Lee Geismer looking over an NDA at FDA in the 1960s.

That was in the 1960's, the "good ole days". It's only gotten more complex, more daunting and requires more paperwork today, with far less drugs than ever, as a percentage of submissions, being granted approval, despite record number of drugs starting out in the labs and phase I research.