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loanranger

08/30/19 8:40 AM

#271745 RE: MinnieM #271725

I asked "Who makes Kevetrin?" because as one of the earlybirds here I'm sure you know that the formulator in 2010 and 2011, Formatech, had some FDA problems and had to cease doing business based on what the FDA felt was an inadequate response to a warning letter that had been sent of 2011. Unfortunately Formatech and CTIX then proceeded to make a new agreement for the drug's manufacture a month later. (In a subsequent court case CTIX said they hadn't been told about the letter while Formatech said they thought they had, or words to that effect.) In any event, CTIX had to find a new manufacturer.

"Celceutix(sic) ‘Back in the Game’ with cGMP Manufacturing Completed on New Cancer Drug
BEVERLY, MA–(Marketwire – Feb 27, 2012) – Cellceutix Corporation (OTCBB: CTIX) (“the Company”), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to announce that the manufacturing of Kevetrin™, the Company’s novel cancer compound for multi-drug resistant cancers, has been completed under cGMP manufacturing conditions by Lyophilization Services of New England, of Bedford, New Hampshire. The vials will be used in Kevetrin’s upcoming Phase I clinical trial."

Lyophilization Services of New England (LSNE), unlike Formatech which filed for bankruptcy protection, is still around but I don't know if they still make K or the last time they did. So obviously I don't know whether they are the source of all the K that is getting peddled all over the place. It would be nice to know who the current mfr of K is and whether their arrangement with this Company allows for them to distribute the product, because it's obvious that someone is doing that and it wouldn't seem likely to be a CRO or a Hospital or IPIX itself.