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Reeling from an unexpected move by regulators, Catalyst Pharmaceuticals (CPRX) is threatening to hit back.

Until recently, the drug maker had been riding high. Last November, the Food and Drug Administration approved its medicine for treating adults with a rare neuromuscular disorder called LEMS, which meant Catalyst has seven years of marketing exclusivity. And despite controversy over its $375,000 price tag, the company appeared to have silenced some critics with assistance programs that kept patient out-of-pocket costs low. Meanwhile, its soaring stock price pleased investors.

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  • Hmmm, the potential for ‘off-label use.’ Is there anyone who actually believes that Catalyst wasn’t counting on the potential for that with their drug in the first place?
    [And as Catalyst ponders/ threatens, one might observe that their projection of a 10x larger market size was a questionable bit of bait [ not fraud, of course] for drawing investors? One might … ]

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