Excited for our pivotal clinical trial. Once IND is filed we are on our way. You are correct. PMCB came out of their pre IND meeting with the FDA recommendation that we do a pivotal trial. This much larger trial takes time to prepare for, but we are finally so close!
The FDA does not make public comments on any meetings with a drug company or a Microcrap scam such as PMCB. The FDA won't even tell you whether any meeting has taken place.