CYP 0.00% 23.5¢ cynata therapeutics limited

Ann: Encouraging Initial Data from CYP-006TK DFU Trial, page-37

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  1. 7,758 Posts.
    lightbulb Created with Sketch. 7023
    No one claimed they did work from this insight and there is absolutely no need to change its trial, its clearly on its way to demonstrating results exactly per its purpose????? The company specifically presented us with initial data and a very simple statistical analysis and made that very clear.

    "Follow-up visits in this trial continue until 24 weeks after the initiation of study treatment. At each follow-up visit, three-dimensional images of the study ulcer are taken using specialised camera equipment. Images are then analysed by a technician who is independent of the clinical site and blind to treatment allocation. This facilitates calculation of the wound surface area, and consequently the change in the size of the wound over time. The analysis of the first 16 patients (n=8 per group) found that the median percentage reduction in wound surface area in the active CYP-006TK group after 10 weeks’ follow-up was 87.6%, compared to 51.1% in the control group."

    Why on earth would they claim safety at this early point???

    And they even specifically they spelt it out for you, if you are that unfamiliar with trial protocols:

    Dr Jolanta Airey MD, Cynata’s Chief Medical Officer, said:

    “These initial results are very promising, and consistent with the previous data readout. We look forward to completing enrolment in the near future, which will take us a step closer to our objective of demonstrating safety and efficacy of CYP-006TK in DFU.”

    They didn't claim it, wouldn't anyway, and even made it tacitly clear in the notes of the limitations of this data (for the ignorant), an insight only, due to the obvious very small sample size:

    "No formal statistical analysis has been performed, due to the preliminary stage of this readout and the small sample size"

    At least read the report properly if you insist on commenting, so you can do so you can try and down-ramp vaguely intelligently.

    (seriously, you are just wasting everyone's time, trying to post such blatantly unfounded FUD)
 
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