Sunday, January 25, 2015 6:19:03 PM
The researchers at Dana Farber requested the following:
"Additionally, the Principal Investigators for the Kevetrin trial have requested that the Company start preparing a presentation to be used for an article on the safety and pharmacological effect of Kevetrin on multiple cancer lines as demonstrated in the clinical trial. Cellceutix interprets this recommendation as a very optimistic sign regarding anticipated outcomes for the trial and clinical advancement of Kevetrin."
It is hard to spin that request as a negative. In effect you have the principal researchers from one of the worlds premier cancer research centers asking CTIX to report on the Kevetrin FDA stage 1 study which has been an astounding success.
http://cellceutix.com/cellceutix-reports-spleen-lesion-disappears-in-patient-with-metastatic-stage-4-ovarian-cancer-in-clinical-trial-of-anti-cancer-drug-kevetrin/#sthash.FVdlRYj0.dpuf
The FDA rquested pharmacokinetic data for Beilacidin:
'In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, including analyses of the recently obtained pharmacokinetic (PK) data. The Company has requested its vendors to assist in preparation of this information for submission as soon as possible. Thereafter, the Company will meet with the FDA to discuss the completed Phase 2b study and to discuss the plans for Phase 3 studies. -"
IMO the importance of this communication is to show CTIX and the FDA are planning the nuts and bolts of the Brilacidin FDA stage 3 trial. Again I do not see how that can be understood as anything but a positive as it IMO certainly presages the announcement of the stage 3 FDA trial
http://cellceutix.com/cellceutix-reports-positive-results-of-brilacidin-in-microbiological-intent-to-treat-population-in-phase-2b-absssi-trial-additional-pharmacokinetic-information-to-be-submitted/#sthash.OOTJ9FrE.dpuf
Good luck, Farrell
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