1) Buy call options and/or shares on a dip ~2 months before the date.
2) Take profits 1-2 days before the date, use some profits to buy puts.
3a) If FDA rejects, sell puts on the crash, pocketing profits again.
3b) If FDA passes, hold the puts. There's usually a price drop anyhow when longs take profits and/or the company sells shares to fund drug production and marketing.
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