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Bio_pete

09/03/19 9:07 AM

#212273 RE: Biobillionair #212271

I'm not sure you can call it BS when the company released a PR stating they anticipated an extension with a new PDUFA date for late December.
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massulo52

09/03/19 9:08 AM

#212274 RE: Biobillionair #212271



FDA Calendar
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PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

Amarin Corp Plc
AMRN
Vascepa (sNDA)
FDA decision on expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study.
12/28/2019
-Drug Status