The bots can make you forget what was said…. Last month, at the...

The bots can make you forget what was said….

Last month, at the Biotech Showcase in San Francisco, Mesoblast Chief Executive Dr Silviu Itescu addressed the audience and said:

"We enter calendar 2019 building upon the successful advancement of our late-stage pipeline where we successfully completed a Phase 3 trial in steroid-refractory acute graft versus host disease (aGVHD) which has near-term commercial potential in the United States (U.S.), and another product candidate having achieved clinical outcomes in line with the U.S. Food and Drug Administration (FDA) guidance for a registrable clinical indication for market authorization, and two additional Phase 3 assets with blockbuster potential. With the momentum of these marquee therapies, we are preparing for multiple milestones and inflection points across these product candidates in the coming year.”

Dr Itescu told meeting attendees that in 2019 Mesoblast plans to work diligently with the FDA to submit a rolling Biologics License Application for use of remestemcel-L in treating aGVHD in children, and will execute on the product candidate’s market access and commercialization strategy.

The meeting attendees were also told that 2019 will be a pivotal year for the Company’s heart failure product candidate Revascor. Mesoblast will meet with the FDA in the first half of 2019 to discuss a potential approval pathway for Revascor in patients with end-stage heart failure and a left ventricular assist device. This follows the clinically meaningful outcomes of reduction in major gastrointestinal bleeding and related hospitalizations achieved in the 159-patient U.S. National Institutes of Health-funded trial in these patients. In addition, Dr Itescu provided the key takeaways on the Phase 3 trial of Revascor for patients with advanced heart failure which has completed recruitment of approximately 570 patients.

*I expect volume to pick up in the coming days*