US Stem Cell Inc (USRM)

[Dragon Lady]

$10-$15 million to complete a phase III trial? I would highly doubt that IMO- it's way, way, way low per any industry norms. That'd be nothing short of pulling a rabbit out of a miracle hat IMO to complete a high quality, FDA level phase III on that amount of money.

It's not uncommon to spend North of $100 million dollars to complete an actual phase III, FDA level/quality trial that'll pass muster of even making it to submission, let alone get reviewed, let alone make it through the gauntlet to FDA approval. $100 million is on the low side actually per industry norms. Reams of data out on the net about the extreme cost and time it takes to get a product candidate through a good, high level phase III and in front of an FDA review board. Phase III can take year(s) as in multiple years to complete- then they have to be written and compiled, the final documents are as thick as a phone book typically, then submitted and then may face numerous review questions- including asking for more trials/data to be conducted and repeated, etc. So even making it to a phase III completion, is far from a slam dunk that leads to an actual approved, salable product- not by a long shot IMO.

Just a few articles discussing the high cost of trials and how tough it is to make it through an FDA submission to an actual approval:

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/

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.manhattan-institute.org/html/fda_05.htm

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

http://www.fiercebiotech.com/slideshows/fda-approvals-2012

Quote from last article:
"Deloitte said last year that the cost of developing a drug had climbed 23% to more than $1 billion, while the average number of late-stage compounds in development fell to 18 from 23. And some of the industry's most anticipated products proved this year to be big disappointments, from the hepatitis C drug Bristol-Myers Squibb ($BMY) scrapped after patients died during a trial, to the very recent failure of Merck's ($MRK) cholesterol fighter Tredaptive, the third blood-lipid remedy it abandoned last year."

That's just a few, there's books written about how difficult an FDA approval is and MASSIVELY costly and get more costly with each yr that passes. It's a daunting task and proposition to say the least. For every 1000 new, "potential" drug product candidates (compounds/molecules, interesting potential "drug" or whatever) a major pharma company introduces in it's initial lab R&D/pipeline or in some University R&D lab, I think I read where something like 2 or 3, maybe 4 are ever expected to have a hope of making it all the way from lab "studies" to probably "animal studies/trials" and then to human trials (phase I, II and then the might phase III hurdle) to eventually an FDA approval and seeing the light of day as a marketable product. The FDA approves like maybe 25 to 35 new drugs on a "good year", that's it. Of all the 100's of bio-techs and all the mega pharmas out there, it's about 25 or 30 approvals in a typical year. The stats are something like that if I remember correctly- daunting. That's why the major pharmas load up their pipelines so huge- they need, must have a "blockbuster" every 5 or 10 yrs or whatever and that "blockbuster" often carries the entire company for the next 5 or 10 yrs while it's under patent. The big pharmas have enormous war chests of cash and spend enormous amounts on R&D and "trials" and buy-out of other companies w/ late stage strong candidate products and all- as they must have a next "new thing" or they die out eventually.