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Your points are all well made. I actually think there are two...

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    Your points are all well made. I actually think there are two issues which are uniquely intertwined.

    FDA approval of "treatment A" requires scientific evidence that treatment A is better or equivalent/less toxic than current SOC for treatment of condition Y..
    It's clear that in respect of Her Vaxx + SOC in advanced gastric cancer this is very likely to be true.
    The phase 2 trial data analysis will likely prove this point.

    Is Her Vaxx, in combination with other current treatments BETTER than current SOC for earlier stage gastric cancer, or indeed other solid tumour malignancies is something that LC and IMU are obviously actively working on. This is still likely to be a science based discussion.
    Who would fund these trials will be important especially as the number of tumours tested and range of combination therapies increase.
    An announcement about a joint trial/funding arrangement could potentially come anytime.
    These are likely to be tumour/therapy combination specific phase 1and 2 trials. They will take time to execute.

    Each of these trails could be used to support an FDA application for approval of Her Vaxx in treatment of "tumour ..........".
    That is the real power of the scientific platform IMU have built. It has significant scalability across multiple tumour lines.

    As the body of evidence for each individual tumour type grows, so does the weight of evidence in favour of the commercial viability of the platform grow, and reduction of financial risk of investment in the platform.

    In addition there is diversity of antigenic targets, PD-1 being a good example. It is also widely expressed across many solid tumour lines.
    So same FDA methodology applies. Same scalability of application applies.

    CF 33 has the ability to generate immune responses across a very broad range of tumour types. Same methodological FDA approach applies.
    Same scalability of application applies.
    (I think of the CF 33 platform is potentially the new mRNA vaccine technology of immuno-oncology it can be tailored to any solid tumour?).

    Obtaining FDA approval for new/innovative treatments is obviously a coveted regulatory/commercial/credibility hurdle.
    One which I suspect would be desirable before committing the types of funds being discussed in this forum.

    It's been interesting to observe how the urgency of COVID-19 has unmasked what can go horribly wrong when large scale commercial/political/diplomatic decisions are made before the usual scientific and regulatory processes are observed.
    (In addition it has also demonstrated that there are sometimes unforeseen complications of immunological therapy when applied across very large scale??).

    I could be wrong, but I don't think many pharma investments at scale will be willing to take that type of gamble?.

    IMHO K



 
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