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Message: BETonMACE USA vs. non-USA brainstorming

Golfyeti,

I wouldn't say that I'm "starting" to wonder about the specifics of the FDA/USA inclusion in BETonMACE. I've been very critical of the lack of information flow since that July 25, 2017 news release. In the news release, DM states "FDA approval to proceed with the Phase 3 BETonMACE trial in the USA is well timed and should not have a major impact on the total duration of the BETonMACE trial." Combine that with the recent BETonMACE timeline slides we've seen that have it extending out to mid-2019, and with the four (not five) months since the news release and still no USA patients enrolled, and with the overall delay in recruitment from completing in Fall 2017 to a revised mid-2018, and with the change to the futility analysis timing from 50% of events to a poorly defined 50-75% of events........long story short.....I cannot allay your fears Golfyeti.....sorry. I guess the good news is the AGM is in 3 weeks and they can't hide from these questions then!

BDAZ

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