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You can find the answer to your first

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ImOnABoat Member Level  Saturday, 01/04/14 03:40:44 PM
Re: Ionthefuture post# 39472
Post # of 91005 
You can find the answer to your first question in regards to their business model starting at page 66 of the following presenation:


In regards to your second question, whether each separate procedure using stem cells has to have FDA approval or some blanket approval instead, I think it is both.

Separate medical conditions treated with stem cells - separate approvals with precisely written-out route of administration, dosage, timing, contraindications, etc etc etc.

Methods of obtaining cells - one blanket approval for the each method, disregarding the conditions it is used for, as long as viability and safety of the cells is proven.

For separate conditions, separate clinical trials will have to be performed to be able to legitimately recommend such treatments for those conditions. As you may find in one of the doctor's YouTube pitches, he used to recommend Intellicells for many things, explicitly calling it "off-label" use. He got smacked with an angry FDA letter for using exactly those words. When a pharmaceutical drug gets approved for certain use (e.g. Viagra for ED), the company can't just say "Well, it is FDA approved for ED, so go ahead and use it for pulmonary hypertension as well." Separate trials proving efficacy in treating pulmonary HTN will have to be conducted... Right now, the entire stem cell market is mostly off-label use because solid clinical trials just now starting to build up. The FDA kinda looks away for now as they themselves are trying to work out a set of guidelines that will regulate this new and rapidly-emerging industry.

So, as the industry emerges, separate companies and non-profit medical entities will be performing separate trials for separate conditions using adipose-derived stem cells, and potentially patent unique treatment methodologies (CYTX has a couple behind their belt already). But this is just about being able to TREAT a certain condition with stem cells. The cells themselves, no matter the condition, will have to be obtained from somewhere else. So once Intellicell gets an explicit green light on marketing their cells as viable and safe, the company can capitalize on EVERY possible treatment out there because all treatments and protocols that other people worked to create and approve will still need one thing - viable and safe cells. So, in essence, other companies, with larger resources, will be worrying about those treatments and protocols being FDA approved so they can patent and perform them. Intellicell just needs ONE approval to PRODUCE and DISTRIBUTE cells within the US - doctors with the power of their medical licenses and observing the current FDA-approved ways will be the ones actually treating the conditions.

I hope all that makes sense.

This post is my personal opinion. I do not provide investment advice.

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