Share Cafe Webinar in March contains critical information on...

Share Cafe Webinar in March contains critical information on Potency Assay data that opens up the path for approval before completion of the new trial for GvHD. SI states that the new data are for a potency assay that was in place during the successful phase III trial for GvHD. This is critical because the FDA stated that the trial couldn't be considered because the potency assay used was inadequate and as such they couldn't be sure the cells used in the trial would be the same as the ones used for the current stock. Assuming the FDA accept the new data and that the potency assay in use in the successful trial is accepted then the FDA can consider the successful phase III trial as being adequate and approve with a post approval confirmatory study. In my view this is really big. There are a few other gems in here as well talking about the rare diseases voucher and onselling it and a reference to off label usage. Well worth the listen.