Feb. 2 at 1:26 PM
$SMMT Buying on dips. Currently looks like FDAs decision in Nov is a red or black bet, but Duggan & co. are not newcomers; confident they have wargamed the heck out of what FDA is likely to say. They would not submit unless they felt the odds of approval are in their favor. Still, there are things, most investors do not think about; i.e they might audit the largest enroller, and find protocol violations; there might be more side effects than they care to disclose. While these are concerns, they also have prior experience in sponsoring multi center cancer trials, dealing with CROs, etc. so must assume these are not issues. Their career openings signal a company that is slowly building the framework for commercialization. Have said it before, in terms of execution, they are one of the best pre-market, no product revenue developmental biotechs I have seen. They exude excellence. That is not a guarantee of FDA approval, but it strengthens conviction. Opinion only. Not Advice.