re: fda approval

My goodness!!

I wonder if the FDA will demand much more onerous tox studies if this ruling holds up?

Will still be important to perform efficacy trials, but with Cormasine Phase II might be enough to generate enough interest to really get sales moving. Note though the ruling apparently only applies where there is no other treatment. So even a useless one if available would close the loophole. Not sure there aren't (useless)treatments available for RCC and Melanoma already which would defeat this advantage for Cormasine?