Re: Legal development: FDA's discretion to declare a product candidate a drug vs a device is limited
Could be a negative for CRMD if a potential competitor were allowed to apply for, say, 46% citrate solution to be approved as a device (as in Europe). Think of all the years and expense to get Neutrolin to this point. Our ace in the hole has been that the FDA insisted on a large expensive multi-phase trials effort. No one else would be dumb enough to attempt a drug approval to compete with Neutrolin given the spectacular results of LOCKIT-100. Let's hope it stays that way until Neutrolin is SOC in all catheters.