potential to serve as a pivotal trial
My understanding is that the phrase "pivotal trial" means that the trial, usually a phase 3, but in this case a phase 2, may lead to approval. Is this not correct? If so, their confidence on this point is stunning, even though the way is is expressed could escape notice by many. How long could the Ph2 trial starting late this year take, and if the FDA could approve under special circumstances w/o an immediate Ph3, could this be approved in say a couple years? For a Ph 2 to be pivotal and result in approval, it would seem to imply one or more of the special categories such as- accelerated approval, breakthrough, etc. Surely some of you know a lot more about this.
“We continued to make significant progress this quarter. Based on our early interactions with the U.S. FDA, we are confident in our submission package for our IND for post-transplant acute myeloid leukemia (AML). In light of the feedback from the FDA, we plan to submit an IND for a Phase 2 clinical trial in the third quarter, which should enable us to enroll the first patient by the end of the year,” said Peter L. Hoang, President & CEO of Marker Therapeutics. “Depending on the results and upon further discussions with the FDA, we believe that if results are positive, this has the potential to serve as a pivotal trial—particularly if results are consistent with data generated to date from our MultiTAA therapies in investigator-sponsored trials. We look forward to initiating our first company-sponsored trial in such an important disease area, for which there are limited treatment options.”
