US Stem Cell Inc (USRM)

[Dragon Lady]

"Stem cells are approved through the BLA panel and are considered biologics"

That is NOT what their response says at all when one reads it in completeness?

The email "question" posed did not ask about a HEART STEM CELL "product" such as Myocell; this FDA answer could be referring to a "skin cream" for all one knows? Also, it doesn't answer a single thing in regards to how much a phase III trial costs or does not cost and/or how difficult and FDA approval is/is not to achieve as they HAVE NEVER APPROVED ANY "stem cell" ANYTHING yet to date, except for ONE, ONE product, "Hemacord". Also, read the recent court ruling regarding a stem cell "product"-

http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/

I'll write the FDA and specifically ask about the Baxter and BHRT phase II/III trials and ask how/what path those will follow in order to gain FDA approval, THAT is the question that needs to be asked. Not how are "stem cells" approved?

That's not what the response says. Not even close. That response is narrow, and specific and spells out a very limited sub set of what is being branded "stem cells", as if ALL "stem cell" anything meet that criteria. Ask in the email HOW MANY STEM CELL "products" and what are the PRODUCT NAMES that have been FDA "approved" under this particular code/section BY THE FDA TO DATE- ask them that.

a) NO "stem cell products" have been approved by the FDA yet other than ONE per their own web site, so how would they know what path a particular "stem cell product" approval would/will follow?

http://www.fda.gov/forconsumers/consumerupdates/ucm286155.htm
"FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system."

b) READ THE RESTRICTIVE DEFINITION- it appears that Myocell would already fall outside the criteria IMO:

"To satisfy these criteria, an HCT/P must be: No more than minimally manipulated (relates to the nature and degree of processing); intended for homologous use only (the product performs the same basic function in the donor as in the recipient); not combined with another article (with some limited exceptions); and the HCT/P does not have a systemic effect and is not dependent on the metabolic activity of living cells for its primary function, or if it does, the HCT/P is intended for autologous use or use by a first-or second-degree blood relative. "
"HCT/Ps that do not meet all of the criteria of 21 CFR Section 1271.10 are also regulated under Section 351 of the PHS Act and/or the Federal Food, Drug and Cosmetic Act as drugs, devices and/or biological products and would require pre- market approval . "

And there ya have it- the court case where "stem cells" were determined to be "highly manipulated" and thus were determined to be a "DRUG". The email didn't answer a thing as related to the scope/type of product BHRT is developing IMO. It's clear. This email for all one knows is referring to a topical skin cream or something, and uses a generic term "stem cells". Unless they, the FDA, specifically answer a question in regards to a current trial, such as listed on clinicaltrials.gov, then I don't think one can know how or what "channel" that particular product/process will follow to approval and this email pretty much says just that- it's a "case by case basis" and the scope is determined by numerous factors that can shift under various parts of the regulatory code. And again, the recent court case ruling is the most plain example of that very scenario- the guy/company was arguing that very narrow criteria spelled out above, the FDA said NO, you're outside that criteria and now you have a "DRUG" on your hands, and the appellate court just upheld that decision, IMO

http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/

And again, NOTHING in this scenario has any bearing on what a FDA phase III trial cost or does not cost and how difficult it is or is not to gain and FDA "approval" for a particular "stem cell" product.

http://www.nbcnews.com/id/36849354/ns/health-heart_health/t/sick-desperate-fueling-stem-cell-tourism/#.U-52ZcVjWQl

Written in 2010 and what did one of the world leading experts in the article, a leader in current stem cell research say:
"Researchers estimate the cost of a three-phase stem-cell trial will be upward of $50 million, with a 10-year time table. "

http://www.npr.org/2010/07/26/128696529/offshore-stem-cell-clinics-sell-hope-not-science

Simple.