Repost of thoughts on SA re Hoosier Investor (HI)

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biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Repost of thoughts on SA re Hoosier Investor (HI)

Post by biopearl123 » Tue Jun 18, 2019 7:24 am

HI, 1. Speaking of slide 9, it appears that 3 of the patients who achieved 24 week TI are no longer on treatment. Could these represent CRs who no longer need treatment (at least up to the point of analysis?). 2. We still don't know if any patients evolved to AML, it would seem especially unlikely for the CR + marrow CRs to do so, if so this would support the next study being in higher risk MDS. 3. HI, CKTC, Curion can you please speculate what would stop the FDA from some form of accelerated approval in MDS (e.g. P IV) at this point given all of the FDA guidance that would seem to want to facilitate approval? I want to make a WAG that the reason enrollment seems to be delayed a little (to Aug--the data cut for the abstract was April 30th) might be to see if some arbitrary threshold (like crossing the 50% 8 week TI rate) might be achieved to influence the FDAs guidance. Do not throw tomatoes. As HI points out we are REALLY close to the 50% mark but of course none of us knows what criterion the FDA might use to accelerate the PIII study. The data in both studies is quite remarkable, showing that to move a market requires something else. Thanks and Best Regards, bp

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