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Thread: learning about following FDA events

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    Junior Member tuxedocat is on a distinguished road
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    Default learning about following FDA events

    Hi, I'm new to this site. I'm just beginning to learn about following FDA events and trading on the run-ups/downs preceding them. I would like to recover the $ (and the anticipated gains) I lost with ARNA - very dumb investing, that, on my part. So I'm researching short-term moves to build my account back up. Right now I'm trying to do some DD on ISTA, AMLN, IRIS, AVNR, BIOD and DCTH, all of which have Oct FDA events.

    Could anyone list a few websites which are good for doing DD, please? I know about seeking alpha, the street and a few other common ones, but sometimes I have trouble finding any info about a company. It's also sometimes hard to verify the FDA dates - many company websites don't seem to mention them at all. Wonder why.

    TIA - I'm looking forward to being a wiser trader and, hopefully soon, investor.


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    Junior Member drchik23 is on a distinguished road
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    gekkowire.com is also good for biotechs. but i like seeking alpha better.

    as for avnr, i can give you some important info as follows:

    they expect decision by october 30th for their drug to treat PBA. according to them, it's a billion dollar field. were rejected back in 2006. since then, have dropped the dosage of their formulation which consists of dexomethorphan (cough suppresant) and quinidine (anti-arrythmic).

    positives include: SPA with fda, insures that if they've done exactly what fda wanted and achieved good results, drug should be approved without tedious delays. (however, VVUS also has an spa with fda and i think they will likely get denied this month.)
    star trial recently completed with tremendous data results
    same guys/girls from fda to vote on approval as those they've been working with to approve drug
    short interest has risen from 2 million to over 12 million in recent 3 months.
    drug may one day have value for diabetic neuropathy---most of the guys on avnr board have a good background in this area as well

    negatives: $75 million dilution feasible according to company before or after PDUFA date
    most drugs in october getting denied
    fda is subjective---even if you do everything right and get good results, they may still not approve.

    for more detailed info check out the sites i mentioned and good luck.

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