CYP 0.00% 21.0¢ cynata therapeutics limited

The DFU information was released with the CR presentation back...

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    The DFU information was released with the CR presentation back in April (slides 17-19): https://cdn-api.markitdigital.com/apiman-gateway/CommSec/commsec-node-api/1.0/event/document/1410-02652273-7NSCRSUGSJJKGVONAOHJ1S31OE/pdf?access_token=0007YUZeQM9jdt0x5ryaOwTUcoAr

    What is notable is the inclusion of more preclinical data demonstrating Cymerus MSCs reduction of heterogeneity compared to tissue-derived MSCs. Heterogeneity is a major hurdle to the commercialisation of MSC therapies. As the FDA noted in the ODAC briefing document for Rem-L, in the absence of outstanding results from a well-controlled clinical trial, the therapy at the very least needs to have a mechanism of action (MOA) consistent with what is observed in laboratory testing. If the underlying treatment is not consistent on a batch-to-batch basis, that makes it difficult to achieve. Fortunately, a single blood donation is the foundation for 21 million clinical doses of Cymerus MSCs, greatly improving the probability that the clinical MOA will closely match what is expected.
    Last edited by truss20: 20/09/23
 
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