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Biodel (BIOD) +12.7% premarket after the biopharma company reported positive top-line results...

Biodel (BIOD) +12.7% premarket after the biopharma company reported positive top-line results from a Phase 1 clinical trial of two ultra-rapid-acting insulin analog candidates conducted to evaluate pharmacokinetic and injection site toleration profiles relative to Humalog, a rapid-acting insulin analog.
Comments (4)
  • Michael Bryant
    , contributor
    Comments (5432) | Send Message
     
    If approved, bad news for (NVO). But I doubt it would be approved.
    24 Jan 2013, 10:04 AM Reply Like
  • TheBigFella
    , contributor
    Comments (47) | Send Message
     
    Why do you doubt it would be approved Michael? I don't want to get to far ahead here, as this is just phase 1 results, however the insulin that was used in this study was provided to Biodel by an unnamed big pharma company who gave them permission to reformulate it. Does that make this news more interesting?
    24 Jan 2013, 03:07 PM Reply Like
  • Michael Bryant
    , contributor
    Comments (5432) | Send Message
     
    The last insulin they made was rejected. I don't understand exactly why. It seemed very safe to me. Wonder if there was any politics in the FDA's decision. (NVO) has 90% of the current market for insulin. (BIOD)'s insulin would be a major threat to (NVO)'s market share. So I assume a similar outcome. Of course, this is just a guess, and I could be wrong.
    24 Jan 2013, 04:17 PM Reply Like
  • TheBigFella
    , contributor
    Comments (47) | Send Message
     
    Thanks for the reply, There is a long terrible history with Biodel. The FDA rejection was due to bungled trials that were conducted in India. There were issues with tainted samples and rather than conduct another trial, the company filed an NDA in the hope that things would turn out . Well, they didnt. Back then the joke was that someone left the blood samples on the runway at the airport. Anyhow, the company abandoned that formulation of insulin rather than try to take it back to the FDA. in other words that was then, this is now. The company seems to have turned things around and is moving in the right direction. Phase 2 results from a different formulation are due out in a few months. Take care and good luck.
    24 Jan 2013, 06:49 PM Reply Like
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