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clock Created with Sketch. 29/04/22
14:08
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Originally posted by JB1975:
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"To me this indicates that the Board feel that they have better oversight of important non-public matters e..g. peer reviews, FDA informal discussions , durability results, and so have better control of information about the outcomes being sought." informally at this stage. MSB has a huge amount at stake and the FDA officers dealing with MSB must know that. And the FDA does very little by way of informal communication at the best of times - even early in the development programs. Mesoblast has generated substantial new data, as previously discussed, that it believes establish the relevance of the proposed potency assay measuring remestemcel-L's in vitro anti-inflammatory and immunomodulatory activity to the in vivo clinical effect of the product in the Phase 3 trial in children wuth SR-aGvHD, including survival and biomarkers of in vivo activity" An enormous amount of time and money (MSB's time and money) swings on whether what MSB believes to be the case will ultimately turn out to be the case and on whether the FDA will believe as MSB does.
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The wording is very important. Anything other than "believes" and the Class Action clowns are sharpening their pitchforks. alleged
(20min delay)
