the dogs suffered what we all are familiar with when a human is having tough chemo response. Nausea, diarrhea, vomiting, blood profile changed that did look to be related to the dehydration induced by those negative effects. This is a novel agent - new territory - initial equivalent human mg/kg starting dose based on  animal studies is scant. They will quickly ramp up watching for negative effects the whole time. FDA guidance suggest initial starting human dose is 1/10th of the human dose equivalent seen to cause adverse events in animal studies.The bulk of this study, as we know, is about tolerability and toxicity.What the drug does to the body and what the body does to the drug. If humans can't tolerate it, it will go no farther. Preclinical data, both cellular and animal studies, offer good guidance but the human liver is ultimately unique in its enzymatic pathway system and thus is unpredictable.

Kevetrin is less toxic than most cancer therapies so far. That may not change in humans. We'll see. Tolerability is huge issue too. We'll know soon. I am hopeful because of the preclinical studies that this will be fairly well tolerated with low toxicity in humans. Most drugs never make it out of preclinical phase. Most drugs are not tested in DF. I think this drug is a stand alone phenomenon and will be well tolerated with low toxicity. So far, there is no evidence to indicate otherwise.