FDA’s CRL…with an unmet life saving condition for children 12 yrs & under in the absence of any big Pharma SOC treatment or therapy. Not even an EUA ?
Why would the FDA grant an EUA when the company is supplying the treatment for free to those that want it through the EAP ? Sad but that is the reality ... the company continues to do the right thing and supply the treatment probably because SI has a conscience and the silver lining is that Mesoblast is obtaining additional data through the EAP to support the BLA resubmission, so there is that
Page 13 Third Quarter Results Presentation dated 1 June 2022
FDA’s CRL…with an unmet life saving condition for children 12...
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