Mesoblast Ltd ADR (MESO)

[cjstocksup]

MESO should be a couple hundred dollar stock ahead. Just with last weeks news we should be well over $100.00 per share.

MESO Info - small trial (MSC) in London.

China 7 patients - https://t.co/ZhY9iYSiTK?amp=1


The stem cell therapy is currently being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory acute graft-vs.-host disease (aGVHD). The company submitted the final module of a rolling BLA in January 2020. The FDA has set a PDUFA date of Sept. 30 for the product branded as Ryoncil. The clinical data submitted with the BLA showed a survival rate of 79% compared to an expected 30% survival rate in the pediatric phase III trial in aGVHD. “Up to now we’ve been focused on GVHD, so we’ll need to ramp up manufacturing,” the CEO said, adding that he is in active partnering discussions. MESO CHRONIC HEART FAILURE Phase 3 trial (DREAM) 566 randomized patients shall report top-line any time now. 1) an interim futility test which tested safety and efficacy of primary endpoints which was successfully passed. 2) the recent comments of the Data Monitoring Controller at the end of the trial, who is the only person who is un-blinded throughout. 3) Mesoblast having already achieved a major reduction in ischemic cardiac bleeding events in the independently sponsored LVAD trials. 4) the placebo adjusted Results of the phase Two MPC 150m dosage in showing significant improvement in systolic performance of the left ventricle CHRONIC LOWER BACK PAIN Phase 3 trial has just ended and awaiting results. In a Phase 2 trial of 100 patients, randomized placebo/controlled, a single injection of MSC's into the disc in patients with severe chronic disabling back pain resulted in substantial improvement in pain and improvement in function for up to two years in a significantly greater proportion of patients than in the placebo group. The degree of improvement in pain and improvement in function was of an order that was very similar to what one would expect if you underwent a surgical procedure to replace the disc and this is with a simple outpatient procedure and injection that takes no more than about 20 minutes. (Mid 2020)

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