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10.0¢ amplia therapeutics limited

Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-15

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leveller

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31/07/24

13:17

Post #: 75003942
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Originally posted by vrs37: ↑

@GoldStar112 Duke is right, in the end this has to be proven through a phase 3 RCT, narmafot + chemo versus chemo alone.

You raise a good question though. In this trial you can sort of try to infer what might be the incremental impact by comparing the response rate (the proportion that achieved the 30% shrinkage) they're seeing here with what was seen in the MPACT pivotal phase 3 with gemcitabine plus abraxane combo in the same patient type of metastatic pancreatic cancer. MPACT trial showed 23% responder rate. ATX have said they need to show at least 6 responders out of the first 26, which is also 23%, before expanding to 50 patients. I'd think this is the bare minimum they can get away with to allow expansion, in the full 50 they'd really need to do much better than 23% responder rate (I don't know what that is, maybe at least 30%?), otherwise why bother going into a hugely expensive phase 3 if all you've shown is the same as the MPACT trial suggesting the narma drug doesn't add anything.

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is the MPACT response threshold the same as the “partial complete response’ criteria the company is using?

ATX Price at posting: 8.8¢ Sentiment: Buy Disclosure: Held
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