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Bighdaddie

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Bighdaddie

Re: None

Monday, 05/14/2018 8:09:48 PM

Monday, May 14, 2018 8:09:48 PM

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Regarding warning letter: "On January 3, 2018 the Company received a warning letter from the US FDA concerning its contract manufacturing services provided to Cells On Ice. The FDA has informed the Company through the letter that the FDA has determined that its autologous adipose derived cell product ATCELL is a drug under current FDA regulations and guidance and requested that the Company to file an Investigational New Drug (IND) application In response to the letter the Company has ceased shipment of its ATCELL product within the United States and is currently in discussions with the FDA concerning the filing of the Investigational New Drug Application in the near future."
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