Phase 3 DREAM HF-1 read-out, page-55

Anjo-roch, Thanks for your post and Specifically Your research on the Head of CBER Peter Marks  ..If the GVHD Meeting with the FDA is not Resolved No doubt Mesoblast will take it to the CBER ...Peter Marks would know Joanne Kurtzberg,s work extremely well in his position as the Director of .CBER, In fact only 6 weeks ago They participated in This  Virtual seminar.........
Regenerative Medicine & Cell Therapies
Date:
Wednesday, September 16, 2020, 9:00am to 6:00pm

Location:
Virtual - register to receive link
Register here for this virtual event.

Co-hosted by the Alliance for Cell Therapy Now, the Regenerative Medicine Foundation, and the Cord Blood Association.

FDA CBER director, Dr. Peter Marks, and other leading experts and luminaries will offer their insights focusing on the rapidly evolving regulatory, funding and scientific landscape in this, the most important virtual conference of the year. Participants can register for this all-day event, free-of charge. To register, click here - http://regmedcelltherapypolicy.org/register/.

As you know, regenerative medicine and cell therapies represent the next generation of groundbreaking treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, ophthalmology, and—most recently—COVID-19. Thousands of clinical trials are now underway, including more than 70 that are exploring the use of cell therapies—including MSCs—for seriously ill patients diagnosed with COVID-19. To get things done, it is mandatory to be informed of current and future public policy initiatives, especially in the age of the pandemic. The familiar pathways of product approval and funding are rapidly changing to address the current crisis..............Accordingly if in fact the decision is up to Peter Marks, Mesoblast is in with a real Chance of the final decision going their way .......My opinion only ..