Much more risk than reward on the coming Friday, page-70

This has been a planned professional hit job , cleverly calculated by those caught very short, the silencing of ecool , the 18% after market MESO crash on the DAX , the miss information by big pharma objectors is no accident , apart from some ambiguous irrelevant questions in the document it actually indicates an approval .
Big Pharma has millions & maybe billions working behind the scenes hoping this never gets approved , their business is treatments, compared to MSB that cures .

Stand firm investors ,the FDA will have no choice but see the merit of approving this life saving treatment where there is nothing else , the alternative is the FDA will make the decision to just let these patients die ?

“7 BENEFIT-RISK CONCLUSIONS

SR-aGVHD is a serious and life-threatening complication of HSCT and represents a clear unmet medical need. Currently there are no approved treatments for SR-aGVHD in patients under the age of 12 and only 1 approved treatment for patients above the age of 12. Patients with severe aGVHD who fail to respond to first-line steroid therapy (ie, SR-aGVHD) have the highest risk of treatment failure with high transplant-related mortality rates. Remestemcel-L was developed to address the need for effective aGVHD treatments that do not further compromise the immune status of children who have received a bone marrow transplant.
Remestemcel-L demonstrated clinically meaningful efficacy in a critically ill population of children with SR-aGVHD. In Pivotal Study GVHD001, the Day 28 OR of 69% was greater than the 45% hypothesized control rate, which was consistent with the MAGIC control cohort.

Day 100 OS was 74% and Day 180 OS was 69%. These clinically meaningful benefits were consistent across disease severity, including in patients with the most severe disease where other therapies have limited efficacy. These results are supported by EAP 275, which showed efficacy in a highly refractory “real-world” population of children with severe aGVHD.
Remestemcel-L was well tolerated with a favorable safety profile compared to currently available therapies. The most frequently reported AEs in Study GVHD001 were those commonly seen in the pediatric SR-aGVHD population, such as infections, GI disorders, and respiratory complications.

The demonstrated efficacy and favorable safety profile of remestemcel-L address a significant unmet medical need in pediatric SR-aGVHD patients, especially in children under the age of 12 years old. Considered in the context of a serious condition for which currently available treatments have limitations, the totality of evidence substantiates the highly favorable clinical benefit-risk profile for remestemcel-L in the treatment of pediatric patients with SR-aGVHD.”

The market must have missed these listed risk benefit conclusions in the document, the FDA will have no choice but to expedite the approval of Remestemcel-L.

But always do your own research !