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Orexigen Therapeutics, Inc. (OREX) Message Board

  • ghostinthemachine81 ghostinthemachine81 Feb 1, 2011 6:37 PM Flag

    Guess I shouldn't be surprised.

    I lost money, but I knew the risks. It was definitely a gamble. 100% gain vs. 70+% losses.

    The FDA is going to require long-term cardiovascular risk trials in all diet drugs from now on. No exeptions PERIOD. They got burned too many times in the past with phenfen, Meridia and other drugs. Fool the FDA once, shame on you. Fool them twice, shame on them.

    So now they're going to require long-term cardiovascular risk trials no matter what.

    It doesn't matter what the drug is made of. If someone came out with a drug made of Coca Cola, the FDA would still require long-term cardiovascular risk trials.

    FDA: You made a diet drug made of 100% water?
    Drug Company: Yes, and it really works.
    FDA: Did you do a long-term cardiovascular risk assessment?
    Drug Company: Uhhh, no.
    FDA: REJECTED. Come back when you've done the tests.

    VVUS and ARNA will get rejected.

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    • <<Fool the FDA once, shame on you. Fool them twice, shame on them.>>

      Being careful and make sure the trials are well planed and conducted is one thing, but here they have gone beyond reason. I believe the FDA's review of future diet drugs will be far and few between and certainly not in the foreseeable future.

    • This may be true - however - the issue lies in the fact that if the FDA wanted the cardiovascular trial to be conducted, then WHY DID THEY NOT DISCLOSE THIS A YEAR AGO. This never came out, ever.

      I am not frustrated as I bought in for the first time today. I am not down $$ here. I purchased specifically on a very valid appeal request. I dont care if the FDA approves the appeal, nor do I care if the FDA EVER approves the drug. I purchased based on the fact that even the appeal being filed will pop this 50%, at which time, I will be dumping.

      The downside here is about .50 cents max as their cash position is about $1.50-$2.00/share. Its a

    • Yes, I agree...FDA has drawn a line in the sand.

      All 3 companies are dead money..

 
OREX
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