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13:37
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Originally posted by otherperspective
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I was listening to the Sarepta conference call live tonight. They had downgraded revenue guidance owing to a number of factors such as the worst flu season for 15 years. One patient died after receiving ELEVIDYS. They had elevated liver enzymes after receiving their gene therapy. After this tragic adverse event, treatment cycles were extended by a further one and a half months while physicians considered the safety implications of this major adverse event. During the Q&A, Serepta were asked about the impact of the recent FDA redundancy programme and they said that they had seen nochange in regulatory response to any of their applications in recent weeks and they were working well with Nicole Verdun…(just like Mesoblast) !competitors seeking to gain approval based around Phase 2 trials using flimsy surrogate or non mortality endpoints . Mesoblast already has full approval for Ryoncil so filing label extensions represent a much easier route to market for additional indications. everyworking day for the last threemonths . At some stage MSB’s share price will have to be upgraded massively based on core revenues. OP
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As I posted to Loopey ….come back in a year with an analysis of all the sackings in regards to approvals
(20min delay)