CYP 2.22% 22.0¢ cynata therapeutics limited

Ann: Quarterly Activity Report & Appendix 4C, page-22

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  1. 35,472 Posts.
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    This part is pertinent....

    "Cynata is also focused on enhancing process development. This involves optimising and expanding manufacturing capabilities to enhance scale‐up efficiencies and progressing Cynata’s US regulatory strategy, to place the Company in a strong position to commercialise its proprietary therapeutic MSC products.

    Commentary from the United States Food and Drug Administration (FDA) late in 2020 provided particularly useful insights into the agency’s position on cell therapy product manufacturing, especially in relation to ensuring product consistency.

    Cynata’s Cymerus process places the Company in a unique position to provide a highly consistent and potent MSC product without encountering the challenges identified by the FDA associated with methods that rely on multiple donors. "
    Last edited by Sector: 28/04/21
 
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