The idea that the FDA would require a Phase 1 for cellulose is absurd. It's in our food, it's in our eye drops, it's in the lips of people who get those dumb lip plumper injections.
If the data from the old P1/2 is not sufficient based on the protocols when it was conducted 17 years ago the FDA will absolutely require a safety phase be conducted. Its not just cellulose its the combination of everything that's part of the treatment.
The idea that the FDA would require a Phase 1 safety study on people literally dying of pancreatic cancer is outrageous. FDA: Hi, before you die we'd like to inject you with CiaB. Oh, no, we won't activate it to see if it works, we just want to see if you get a rash at the injection site...
As stupid as it sounds every treatment goes through FDA protocols. PMCB is no different.