Sat, Apr 19, 2014, 2:27 PM EDT - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Biodel Inc. (BIOD) Message Board

you are viewing a single comment's thread.

view the rest of the posts
  • biod_factman biod_factman Jun 25, 2010 12:48 AM Flag

    Complete Response Letter

    "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.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • The magic word 505b2!!!! If biod had any suspicion about the FDA not approving this due to the India issue, they would have not submitted. It would have been to easy to run another study, especially one that has 80 patients. Heck you can run down to the nearest endo doc an grab 80 patients for a study. The bashers here are probably friends of mannkind....IMO. I can't wait to say I told you so!

 
BIOD
2.38-0.02(-0.83%)Apr 17 3:59 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.
Weibo Corporation
NasdaqGSThu, Apr 17, 2014 4:00 PM EDT