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Biodel Inc. (BIOD) Message Board

  • tydurban tydurban Jun 24, 2010 11:14 PM Flag

    Complete Response Letter

    This stocks drug does not have a chance in hell of being approved by the FDA. Are you f'ing kidding me? The FDA is going to set a precedent that "Yes we do accept mishandled phase 3 trials" as long as you make up for it with abstracts, proffesional opinions or modified data enumeration? They will be required to redo a portion of their phase 3 when they are issued a CRL by the FDA in October or sooner. Never once has their been a drug with a messed up phase 3 trial that was approved right away on the action date. Never. Go ask CTIC management or DSCO. And those drugs are for unmet needs for chrissakes. Sure we will see a runup to $6 or so over the next few months but Ill see you at $2 shortly thereafter. My advice: use options to your advantage.

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    • "Never once has their been a drug with a messed up phase 3 trial that was approved right away on the action date"

      Actually VNDA failed their ph 3 primary endpoint and got approved on PDUFA date last year.

      And there is another one that was in almost identical situation as BIOD that got first pass approval and they had to exclude anomalous data. Name escapes me right now, but I'll post it tomorrow when I come up with it. I'm sure there are many more too.

      Difference with BIOD here is 1) this is a 505 b(2) and that means a lot lower hurdle and 2) the anomalous data is very explainable 3) plenty of statistical power even when excluding India b/c the drug worked so well at the U.S and Germany sites.

      Nevertheless, it is possible we get a CRL in october. I just don't think BIOD will have to do another trial though. Just respond to FDA questions if they get CRL. Slight delay at most.

    • another free advice guy without any short position right? i think you woke up after it fell from 26.

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