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Ann: Imugene HER-Vaxx Phase 2 Clinical Update, page-33

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  1. 403 Posts.
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    Spot on Unbelievable.

    I’ll summarise the current estimated timetable (source: Emergence presentation Feb 20, April Newsletter, and clinical trials link helpfully provided by DTshares post (above) and other info on IMU investor website

    End Q2 (2nd calendar quarter) 2020, probably mid to late June:


    IND Clearance (ie. US FDA clearance of investigational new drug) for PD1 Vaxx phase 1
    IND Clearance CHECK Vacc TNBC (Triple Negative Breast Cancer)
    IND Clearance VAXinia MAST Study phase 1 (Mixed Advanced Solid Tumours)

    Early Q3 2020, perhaps late July

    FPI (First Patient In) PD1 Vaxx phase 1 - ie, underway
    FPI CHECK Vacc

    Mid Q3 2020 perhaps August 2020

    FPI VAXinia

    End Q3 perhaps late September 2020

    HERR Vaxx Phase 2 enrolment completed

    End Q4 2020, ie, December 2020

    HERR Vaxx Phase 2 PFS Readout (Progression Free Survival) ie final data collection date for primary outcome

    End Q2 2021

    PD1 Vaxx Phase 1 OBD (Optimal Biological Dose) [remember with HERR Vaxx there were 3 different dosing levels used to arrive at the the OBD which is used in phase 2]

    This trial will then be expanded which involves additional patients. They are enrolled after the OBD is identified, and other studies have shown that this process has identified a “higher likelihood of success in Phase 2 trials”.

    Early Q2 2021 (according to Clinical Trial info as cited by DTshares updated yesterday 6.5.20) or Mid Q3 2021 on Emergence estimated timeline - obviously Q2 2021 is more recent information

    HERR Vaxx OS Readout (Overall Survival) which is the estimated study completion date)

    Mid Q4 2021

    CHECK Vacc OBD

    Early Q1 2022

    VAXinia OBD

    Late Q1 2022

    PD1 Vaxx trial completed

    End Q2 2022

    VAXinia ICI Combo OBD (Immune Checkpoint Inhibitors in combination with Optimal Biological Dose)


    CAUTION: These are estimates on current information provided by IMU available online.

    I’m very optimistic about IMU and I will genuinely be surprised if something massively positive doesn’t occur well before the end of the above timeline. By that, I mean success of one or more of the products either as a cure, or cure for certain cancers, or positive results that improve quality of life, or positive results of an IMU produce being used in conjunction with some other product that improve quality of life by extension or remission. If any of those outcomes occur it will be a giant step for humanity, and a bit more than spare change in my pocket. That’s only my opinion. You are entitled to yours.


 
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