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Monday, December 30, 2013 8:05:31 AM
As you point out it outlines the companies intentions regarding Kevetrin to seek orphan, fast track, breakthrough type designations specifically for retinoblastoma... it sounds like the IND would be filed in a timely manner and trial in such could commence as early as 2015... pending successful completion of p1... it would be a P2/3 trial...
Love this line from the PR... “While our Phase 1 clinical trial is ongoing, we are planning for future trials that are aimed directly at the latest initiatives of the Food and Drug Administration to expedite development of ‘breakthrough’ technologies to commercialization,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix.
And this one... "Kevetrin has delivered robust results against all indications tested to date. Cellceutix’s strategy is to have multiple trials ongoing against multiple cancer types concurrently. We are conducting testing against several more cancers to delineate the quickest path to market to build corporate and shareholder value.”
Again this is very PCYCish... in that from this point forward new trials look to be initiated with regularity across the developmental pipeline... what is missing right now is simply the cash to pull all of this off... A partnership for Brilacidin following a successful p2b will likely take care of that... everything is coming together nicely... 2014 looks to be a transformative year for CTIX... and one in which the pps will finally begin to reflect the true value of the maturing pipeline... jmo...
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