If the FDA grants any approval it's nirvana for longs - price should hit news highs. But even an *application* for approval would be huge. Even a statement that the trial is fully or full enoughly enrolled to get data in 3-6 months would be enough to make most longs pretty happy, I think. Certainly those buying here or anywhere below $1.
(Warning: it might not turn out so well. There are significant risks so use your own judgement ;-).
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