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slcimmuno

06/03/15 10:02 PM

#106399 RE: To infinity and beyond! #106396

Some Leo responses on Kevetrin

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MY QUESTIONS:

Couple of quick Qs re Kevetrin if you can answer...

1) will more detailed efficacy data be released anytime soon (eg a PR) or will that have to wait until study completion and publication?

LEO: I wish I could be more informative to shareholders. We will continually strive to release more information but in reference to efficacy we need approval from the investigators and they dont like it released in a PR but only in a peer reviewed journal. Usually thats done at the end of a trial. You can imagine the grief I got for talking about the spleen lesion.....but our statement was all true.

2) Is K's true Mechanism of Action understood?

LEO: We have a very good handle on that now. At the end of Phase 1 meeting we can discuss this with the FDA as multiple biomarkers will be looked at in the Phase 2 trial.

frrol

06/04/15 8:24 AM

#106447 RE: To infinity and beyond! #106396

I want to believe Cellceutix told the DF PI around cohort 5, "If you think Kevetrin is showing promise, start steering more patients with S4 ovarian cancer to the trial to build up the data and we'll make that our first solid tumor trial FDA application. And we'll do the trial at DF/BI..."

I am not saying that is what's going on. But unless there was a coincidental spike in ovarian malignancies presenting at DF, what is a more plausible explanation?