Much more risk than reward on the coming Friday, page-96

This Man from the Fin Review that wrote the most negative one eyed reviews must be blind or what ?? he could have caused this share dump that a lawyer mate has a bet over a lunch quoting what he read in the Fin R ???? when I showed him the below he said he has lost the bet , the writer has glossed over the most important part of the discussion paper , and inserted his own view, why ????, The Benefit risk conclusions is the most important part the market and he has disregarded , he has been negative the stock for years consistently, short friends or big pharma friends ???


(ADCOM) “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.