CHM chimeric therapeutics limited

Ann: IND clearance received from US FDA for CHM 1101, page-26

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    They have a lot of data on how this drug works, as it has been in the pipeline for a long time before the CHM float. This is where they are getting their confidence from. The Phase 2b trial will not require a huge patient cohort. This is where the benefit for a small biotech comes in. So manufacture of drug for the Phase 2b trial, will not be that different to the Phase 1 trial. Yes commercialization of the drug will pose challengers, but what a great challenge to have!

    "The new treatment, a called , was approved for patients with mantle cell lymphoma that does not respond to other treatments or has .

    Mantle cell lymphoma arises in , a type of white blood cell. Most people with mantle cell lymphoma are diagnosed with an aggressive form of the disease that has already spread.

    FDA’s approval was based on a , called ZUMA-2, that tested brexucabtagene in 60 patients with mantle cell lymphoma who had received up to five prior treatments. "

    The above is showing that the FDA gave approval of Tecartus CarT from a Phase 2 trial of 60 patients.
    The

 
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