RE:RE:Another GBM trial using ALA...They are further advanced, even if their objective is only tumor regression rather than tumor eradication:
SonALAsense ALA SDT Development
Following the results of the initial Phase 0/2 clinical trial at the Ivy Brain Tumor Center, if as expected we will observe our ALA SDT drug + device combination therapy to be a safe, noninvasive, rapidly acting and tumor regressing new form of GBM therapy, we will seek Breakthrough Designation from the FDA Oncology Division. We will also plan for a single pivotal clinical trial for the purpose of obtaining marketing approval in the US.