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IntelliCell BioSciences, Inc. Message Board

  • athec_99 athec_99 May 12, 2014 11:22 AM Flag

    FDA warning

    From the recently filed 10k, in Dr. LookGood's own words: "The Food and Drug Administration (FDA) has re-inspected our facility in early June (2013) and issued a 483 Report and the Company hasresponded in a timely manner. They may determine that we do not currently meet the guidelines to operate a cell therapy business or that our cell therapy treatments should be treated as a drug."

    Sentiment: Strong Sell

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    • If the FDA imposes device, drug, or biologic regulation on IntelliCells™, we may not be able to obtain the necessary clearance or approval to market IntelliCells™ in a timely manner or at all. Even if we do obtain approval, the cost and delay could materially adversely affect our financial condition, results of operations and cash flows. The FDA allows HCT/Ps (human cell and tissue products) to proceed to market without prior clearance or approval. We believe IntelliCells™ qualify under this foregoing section and under Title 21 of the Code of Federal Regulations, Part 1271.10 (21 C.F.R. § 1271.10), and we have not invoked FDA’s voluntary procedures for seeking a ruling. We cannot assure you that the FDA would agree with our determination. For example, such HCT/Ps must be “minimally manipulated.” We believe that our use of ultrasound cavitation or other physical means, rather than chemical means, to separate non-cellular material and to create IntelliCells™ qualifies as minimal manipulation. However, to our knowledge, the FDA has not publicly addressed the issue of ultrasound cavitation and minimal manipulation, and could disagree. If the FDA were to decide that ultrasound cavitation is more than minimal manipulation, then IntelliCells™ would no longer qualify for these exemptions.
      The FDA may disagree with the Company that using SVFC for regenerative inductions represents homologous use (same basic function) and otherwise meet the conditions of 21 C.F.R. § 1271, If FDA were to disagree, Intellicells™ would require premarket approval as a drug, medical device, or biological product.
      If the FDA were to disagree with our determination, or were to prospectively alter the requirements for HCT/P eligibility, the agency could require us to stop marketing IntelliCells™ until we met burdensome and lengthy medical device, drug, or biologic premarket clearance or approval requirements, which could include a requirement to gather extensive supporting clinical data.

      Sentiment: Strong Sell

    • Wow, I did not see that. Just what little I did read in that 10K was depressing enough.

    • The stock right now could bounce back to 0.0045 or even as high as 0.0050 because the stock is so over sold. When is the bottom going to fall out? is it going to be in another week or two weeks? certainly i would think that one year from now the stock will have crashed by then. because going back to December the stock is basically on a 4 month long up trend and currently is on a 9 week consolidation going back to around some time in march. on the PEII board a basher told me that me selling PEII for a small lost at 0.0017 was a good idea and now PEII is at 0.0009 a share and if i continued to hold PEII i would have been more then crippled i would have been completely devastated. So Athec_99 i do know that you Basher people con be right sometimes so im really starting to think SVFC could potentially be a bad investment.

      • 2 Replies to necropolis20us
      • @athec_99 - im sorry i called you a basher please excuse me. its just i did not know it was possible to have negative outlook and only watching a stock from sidelines. i personally also have a negative outlook and im on the sidelines but i still would rate as a regular buy instead of Strong buy i beilive that the stock is getting ready to bounce about 30% off of today's low of $0.0035. but im no long in the strong buyer camp. im starting to think that the stock is not going to go back to that above a penny price we svfc holders had back in February or March or when ever that was.

        Sentiment: Buy

      • Necro, I'll say this again and again, I am not a 'basher' here! Everything I have posted is straight forward and I leave it to anyone reading to do their own Due Diligence. And DD is not just relying ONLY on the words of the CEO and/or the company's public relations network. DD is doing the hard work and research and sometimes the result from that is a negative outlook. And that's what it is here, VERY NEGATIVE. Dr. LookGood has proven time and time again that running a business is not his strength - accumulating debt and defaulting on that debt is a long, time honored tradition of his. I'm not making this up - the DD leads me there. He may be a good cosmetic surgeon, but that's about it.

        Sentiment: Strong Sell

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