RE:RE:RE:Once pre-BTD was submitted When Study II was being set up (back before the pandemic and shutdown), it was explained that only a Phase II trial would be required. However, if successful, then in lieu of the Phase III trial, Theralase would be required to keep a registry of all patients up through 300 in order to verify that the initial results from Study II are being maintained as the drug goes into general use.
This requirement resulted from the large number of recalled drugs in the period 2016-2022 when 18 of 35 approved drugs had to be recalled when general use results of those drugs failed to show the same efficacy and/or safety as were shown in the clinical trials.