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This is not unusual, as when small biotechs such as AVXS see significant success and potential revenue they tend to follow the money and focus on their most promising product (which happens to be involved in 60% of SMA cases hence a larger potential profit). To that effect, AVXS put a second nail in the short thesis that the FDA was not supportive when it recently announced that the FDA had approved its Phase III Pivotal trial for SMA1, which started in October 2017.Trial Design With regard to the trial and its designs, bears have focused on the single arm design of the Phase I and II trials (and upcoming Phase III trial) as a poor means for analysis and highly unusual. Let us start by staying two things, one of which may be obvious if the FDA did not have faith in the significance of AVXS's product, or the effectiveness of a single arm trial, it would not have approved it for further trials in humans.
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