I’m not familiar, most CRLs I’ve seen had some
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Posted On: 09/07/2019 4:17:31 AM
I’m not familiar, most CRLs I’ve seen had some safety issues. Maybe some efficacy also, because safety issues in pre clinical models seems weak.
With the great safety profile we have, it should not be an issue.
A quick google search,
The CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides. Renal toxicity with golodirsen was observed in pre-clinical models at doses that were ten-fold higher than the dose used in clinical studies. Renal toxicity was not observed in Study 4053-101, on which the application for golodirsen was based.
With the great safety profile we have, it should not be an issue.
A quick google search,
The CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides. Renal toxicity with golodirsen was observed in pre-clinical models at doses that were ten-fold higher than the dose used in clinical studies. Renal toxicity was not observed in Study 4053-101, on which the application for golodirsen was based.
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