Sorry, been a bit tardy, seems an update might be in order as FDA progress expected by company in next quarter, the OTAT potency and CMC discussions probably the most critical:
COVID-19 ARDS:
"Mesoblast met with the United States Food & Drug Administration (FDA) in regard to potential emergency use authorization (EUA) for remestemcel-L in the treatment of ventilator dependent patients with moderate or severe acute respiratory distress syndrome (ARDS) due to COVID-19. The FDA advised Mesoblast that an additional clinical study in COVID ARDS would be required which, if statistically positive, could provide a dataset in conjunction with the recently completed 222 patient clinical study that might be sufficient to support an EUA. FDA provided guidance that the existing COVID ARDS Investigational New Drug (IND) file and future submissions for remestemcel-L in this indication may continue to cross-reference manufacturing information in Biologics License Application (BLA) 125706 for pediatric steroid refractory acute graft versus host disease (SR-aGVHD). FDA indicated that potency assays must be established and agreed prior to commencement of the proposed Phase 3 clinical trial. FDA indicated that the potency assays currently in development appeared to be reasonable based on in vitro results provided in the briefing document, the in vitro activity of the product appears to be relatively well established, though the relationship between in vitro activity and the product’s actual mechanism of action remains theoretical".
"Mesoblast intends to meet with FDA’s Office of Tissue and Advanced Therapies (OTAT) in Q4 CY21 to address potency assays for remestemcel-L in relation to SR-aGvHD, attributes which we believe to be also relevant to COVID ARDS". (31 August)
CHF:
"Mesoblast filed requests and expects to hold meetings with the FDA during the next two quarters to discuss the pathways to US regulatory approvals for its second technology platform rexlemestrocel-L following the recently completed Phase 3 trials in patients with chronic heart failure...." (30 July)
"Based on observed reduction in mortality and morbidity in this Phase 3 trial, Mesoblast expects to receive feedback in the next quarter from FDA on potential approval pathways". (31 August)
CLBP:
“Mesoblast has filed a request and expects to hold a Type C meeting with the US Food & Drug Administration (FDA) during the current quarter to discuss the pathway to US regulatory approval for rexlemestrocel-L following the recently completed 404 patient Phase 3 trial in patients with chronic inflammatory back pain due to degenerative disc disease.” (1 July)
"Mesoblast filed requests and expects to hold meetings with the FDA during the next two quarters to discuss the pathways to US regulatory approvals for its second technology platform rexlemestrocel-L following the recently completed Phase 3 trials in patients with....chronic inflammatory back pain due to degenerative disc disease." (30 July)
Based on the above results from this Phase 3 trial, Mesoblast expects to receive feedback in the next quarter from FDA on potential approval pathways". (31 August)
srGVHD:
"Mesoblast continues to be in discussion with the FDA through a well-established regulatory process that may include a resubmission with a six-month review with the aim of achieving approval of remestemcel-L in the treatment of SR-aGVHD in children. The FDA’s Center for Biologics Evaluation and Research (CBER) has recommended that Mesoblast as a next step discuss with CBER’s review team at OTAT our approach to address certain outstanding chemistry, manufacturing and controls (CMC) items, including potency assays, which could support a resubmission of the current BLA. Mesoblast intends to meet with FDA’s OTAT in Q4 CY21, to address potency assays and otheroutstanding CMC items". (31 August)
(20min delay)