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Amarin Corporation plc Message Board

  • williams4076 williams4076 Jul 28, 2012 11:17 AM Flag

    NCE status listed on FDA website, just not in Orange Book until August

    Do a new drug search here:
    http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

    Type in Qsymia that's Vivus's new weight loss drug. Note that RLD code is TBDi
    Then note the TE code: TBDi

    Qsymia and Vascepa with both be updated in the Orange book at the same time.

    Now compare this to a Vescepa search, note the RLD is TBDi the same as Qsymia. But the TE code is none for Vescepa NOT TBDi.

    I emailed the FDA they responded within one hour. They stated that the company was responsible for announcing the NCE status and by policy they can not release this information. The FDA did not state that the NCE status was TBD. This was NOT a form e-mail, I emailed an individual and they responded. I did reference the Bloomberg article and complaint to the SEC also;)

    Icosapent Ethyl has no bioequivalent, No TE code "none". IMO NCE status has been given to Amarin in some form...unofficially...Maybe, but they know. They may be withholding this information at this time for negotiation purposes...???

    IMO "none" in the TE Code predicts a NCE status in the Orange Book.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • It would certainly set a precedent, deterring future prospective studies of other potential helpful drugs. You would remove the incentive and investment of time and money to run trials to test new ideas if you allow generics to ride one's coattails.

    • One could argue that if two molecular drugs are exactly the same chemically, they should have the same exact pharmacological effect. If they have different effects, as we have with Lovaza and Vascepa, then it is obvious their molecular compounds are different. Therefore, it is of my opinion they receive NCE.
      They did not spend $200 million in 2-3 years on 2 Phase III successful trials,17 employee salaries,filing fees to USTPO and filing fees to the FDA, to end up beind the other generic Lovaza.

    • father_mari@ymail.com father_mari Jul 28, 2012 5:48 PM Flag

      Hold on there bozo.

      Aren't you the one who didn't even know what amr-101 is made of? Ya, that was you.

      For some reason, you thought amr-101 didn't come from fish oil. You thought it was magically created out of mysterious chemicals.




      And you want to continue giving YOUR opinion? No thank you sir.

      I simply ask that you preserve all of your raging ignorance for yourself. Again, I thank you.

      ………………………………………
      ………………………………………



      What the he11 do you think

      ………………………………………

      4-Jul-12 06:29 pm
      • williams4076


      Plus EPA is made from the fish in the sea, correct?

      AMR101 is chemically engineered by a pharmaceutical company.

      With the Anchor and Marine indication, Plus EPA wouldn't pass the purity or supply demand for the REAL pharmaceutical grade AMR 101.


      ………………………………………

      2-Jul-12 10:18 pm
      • williams4076


      It's produced in a lab not fished out of the sea. No drug developed from fish or krill products will be able to meet AMR 101 indication.


      ………………………………………

      2-Jul-12 11:03 am
      • williams4076

      Honestly, anything that has to be caught in a net will not fill the market need.

      What's the chemical entity that producing the results? EPA? Unknown?


      ………………………………………

      1-Jul-12 06:39 pm
      • williams4076

      Also made from fish...not enough fish caught to maintain the population that AMR 101 is marketing to.

      Fish breath?


      ………………………………………

      27-Jun-12 11:20 pm
      • williams4076


      AMR 101 doesn't kill any innocent fish, it made in a food lab.


      ………………………………………

    • This is copied from the FDA website.

      . Therapeutic Equivalence Codes (TE) Definition of TE codes13

      If the TE Code column says "None," one of the following conditions applies:
      The product is a an Over-the-Counter14 (OTC) drug.
      The product is a brand-name drug that does not have any therapeutic equivalents (There are no therapeutically equivalent generic drugs.)
      The product was approved as a Tentative Approval15.
      The product's marketing status is "Discontinued16."

      If the TE Code column says "TBD," the product was recently approved, and FDA has not yet determined Therapeutic Equivalence

      I do not think this has anything to do with NCE status.

    • You are spreading false information. NCE status is NOT made known at the time of approval, not to the drug company or anyone else. The FDA announces NCE status one way and one way ONLY. That is publication in the "Orange Book" which is released the month AFTER approval. In fact the FDA does NOT even send any form of written communication to the drug company involved. The drug company itself has to wait for the OB to be published ro find out the FDA's decision. Amarin does not know the status of the NCE, NOBODY does at this point except for the FDA and they will make that know like I said in one way-through the Orange Book which will come out the second week of Aug. If you doubt my info just spend some time on the FDA web site and educate yourself and see first hand how your info is wrong.

    • what does TBDi stand for?

    • what does TBDi stbad for?

    • TE code = Therapeutic Equivalence

    • I should have posted TE definition, sorry.

      Link to FDA, just scroll down to T's;)

    • Williams...That argument holds no weight..

      Look up Rayos....Just approved and certainly can not get NCE...Yet in the TE code = none....

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