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Intercept Pharmaceuticals, Inc. Message Board

  • gran_pa gran_pa May 30, 2014 12:20 PM Flag

    Legal question

    When OCA is approved and availabe for PBC, what will prevent NASH patients from getting it themselves if they are willing to sign papers releasing treating physicians and institutions from liability? Can the FDA stop them legally? There are patients now that refuse blood transfusions for religious reason.

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    • This is a very good point. ICPT will have to be VERY careful to avoid promoting for NASH in any way. The FDA will be looking for that. Also, don't forget that you are probably talking about a very large NASH clinical trial, so patients who want to get the drug may want to enroll in the trial. Lastly, pricing - any OCA prescription will definitely be reviewed by insurers, and with the likely price there won't be many willing to pay out of pocket for off label use, so a prior auth review by the insurer's pharmacy will probably limit any off label usage.

    • Maybe the NASH patient would better take a GFT505 which is safe and efficient for NASH (at this point of the trial 2B with DSMB Ok/Fast Track for NASH etc...)
      If YOU had the choice, what would you take ? Take a look at the GFT505 from GENFIT ...

      • 2 Replies to jmlfr28
      • Sure .. At the end of the game .. OCA will be used for PCB and GFT505 will be used for the NASH...

        It explain why the intercept share will probably fall and the genfit one will climb

        The funds know that now .. They just want small investors to by their share at a decent price.. And the analysts announcing target like 600 or 800 bucks are just working for them..

        Thats my opinion .. When the funds will be out .. The analysts will suddenly discover the unability of the OCA to cure the NASH on a long term basis because of the critical safety problems and they wil talk about competitors....

        I am not an intercept shareholder ,, i am a genfit one and that can influence my jugement...

    • I posted this question because if the FDA cannot stop NASH patients from getting the drug then you do not need the FDA to approve OCA for NASH indication. If FDA can, then NASH patients will get the treatment outside this country if the drug is available elsewhere.

      • 1 Reply to gran_pa
      • Its not the FDA that cannot stop physicians from prescribing to NASH. Its whether the physician is willing to take the risk in prescribing OCA to these patients. With the elevated LDL, are they willing to take the risk full knowning its not fda approval and risk for a cardiovascular event. We live in a sue happy country and patients will sue physicians for anything, whether for a heart attack from a drug or possibly even for elevated LDL given the drug is not FDA approved. I doubt you will see physicians prescribe it off label without the FDA's approval.

        Sentiment: Hold

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