When FDA approves drugs, do we know ahead of time when the approval is scheduled or does it come by surprise?

Sarepta has this new drug that treats a rare disease.....

it seeks accelerated approval from the FDA........

the FDA's approval/denial can greatly impact its stock price.

here's my question:

Do we know ahead of time the DATE of the approval/denial?

or does it just pop up by surprise?

do they announce it when the stock market is open?

1 Answer

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  • 8 years ago
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    The FDA committee meetings that approve/deny a new drug are publicly scheduled.

    However, from experience, that info isn't easy to find.

    So, key votes on new drugs ARE known ahead of time. However, there are plenty of times the decision is deferred for one reason or another.

    Yes, they may be announced when the market is open.

    For most of us regular investors, trying to capture the change in stock price from a new drug is a big gamble. First of all, professional investors have a lot more info than we do, not to mention $$$.

    Second of all, it's hard to know that Drug X will in truth be a blockbuster.

    As a drug goes through trials, the results are made public. So, when a final FDA decision time comes, the market may have already taken the results into account and priced the stock accordingly.

    Source(s): PA
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