In addition to nothing being guaranteed, esp. with binary events like FDA approval, another thing many (new) investors seem to be unaware of is that approvals tend to get priced in, not completely, but in some amount, as the decision day approaches. Not just with this stock, with any biotech with pending FDA decision, this is usually the case. Therefore, talks of share price doubling from current level (whatever it may be in the next couple of weeks) are risky. On approval it may double temporarily but don't forget that the appreciation we are seeing till now comprises of some of the approved value being priced in. So do not chase a big run on approval day as it will pull back most certainly and it will be up to the next quarter's revenue to push it higher again. Just my two cents.
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