Quick footnote to add further light on this subject: many of the old school chemo drugs that are still in use act more indiscriminately against cells and hit cells hard that turn over quickly…these include the cells which line the GI track and skin and is why rashes and GI upset are so common with these drugs…again stressing the point was it the drug given, perhaps another different drug, or the disease itself. That’s why you need a principal investigator weigh in at the trial site level who can view it independently.

The FDA paperwork underway will have all this under a microscope and I suspect will result in a yawn from the FDA reviewers.