More insight into the Italian study (speculative)

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biopearl123
Posts: 210
Joined: Fri Jul 20, 2018 5:13 pm

More insight into the Italian study (speculative)

Post by biopearl123 » Wed Oct 02, 2019 6:11 pm

As everyone knows the MF clinical trials site was updated on in July to reflect the addition of a single Italian site (that interestingly was the source of a study suggesting MOS of 22 months). Also during this time period Geron would have had to initiated application for fast track (FT is initiated by a company, not the FDA and application must be acted on by the FDA within 60 days). This means that the latest application could have been made was the end of July in order to have action by Sept 30th (positive action, as we know). This suggests to me the the results from the analysis of data from the Italian site was known at the time of FDA application for FT and supported this designation. We will know for sure at ASH. This is just all speculation at this point but the timelines are interesting. Also I think we can expect an expansion of the number of worldwide sites for the MDS study based on the Oct company presentation. Once up and running this study should enroll very quickly. bp

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