Provectus Biopharmaceuticals Inc (PVCT)

[vorlon1966]

They have insurance for those lawsuits if need be. I am expecting them to go away though.....there is nothing they did wrong.

The endpoints are standard PIII endpoints so they are safe to use them. The chemo comparator is used instead of a placebo. A proper comparator would be an approved red injectible drug but no other exists. The FDA did not want to fool around with the complications of the bystander effect (something the FDA is not ready for yet) so they have instructed them to treat all the lesions.......something that should produce very good data.

They are not out of touch with the FDA....rather, the FDA has a system in place that is out of date for these new types of drugs. How do you measure progression when the tumor goes away quick? How do you measure pain response where there is none? The number zero does not work well in statistical equations. The tried and true FDA PIII's always assumed the patient might get better by a percentage.

Remember this is a whole new way of treating cancer.