Seeking Alpha

Chelsea Therapeutics says FDA action postponed until Tuesday

  • The suspense continues: Chelsea Therapeutics (CHTP) says the FDA has notified it that the decision date for the Northera new drug application has been extended to Feb. 18 due to an office closure caused by severe weather.
  • Shares, which had been down more than 20% AH, now +1.4%.
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Comments (15)
  • GreenGrowthGeek
    , contributor
    Comments (1267) | Send Message
     
    Good news for investors.
    14 Feb 2014, 07:24 PM Reply Like
  • dhdhoora
    , contributor
    Comments (575) | Send Message
     
    LOL. They could have issued this statement this morning and saved a lot of gnashing of teeth. My guess is that the FDA and Chelsea are 'negotiating' some kind of label deal. Clearly the FDA is not shutting down the drug, but clearly they have problems with a full approval. <p class="double"> <... the very best,
    Don
    14 Feb 2014, 07:29 PM Reply Like
  • Grant Payne
    , contributor
    Comments (331) | Send Message
     
    I don't know, I think it's likely that they simply delayed the decision because of weather. If the FDA wanted more time to deliberate they'd just say it, they don't have compunction with delaying a decision even though they know it has a big stock behavior effect. Weather as an excuse would just be too convenient. No doubt there's a chance its approval is diluted with labeling stipulations though.
    14 Feb 2014, 09:46 PM Reply Like
  • Andre LaPlume
    , contributor
    Comments (427) | Send Message
     
    I'm not even a shareholder, but I was enjoying the drama. FDA could have said it Friday morning. But they are a world unto themselves, and are accountable to no one.
    15 Feb 2014, 07:21 AM Reply Like
  • Grant Payne
    , contributor
    Comments (331) | Send Message
     
    Ha ha yeah it's a bit of a spectacle that's for sure. I'm long with a small amount of calls, and hedging with puts. The FDA should have some sort of public notice system that lets industry know they're having a snow day... So many people got thwacked because of the volatility. A lot of people's stops were triggered simply because the FDA didn't communicate, I wonder how mad they'll be if the stock pops on FDA approval this Tuesday.
    15 Feb 2014, 03:57 PM Reply Like
  • hneumann
    , contributor
    Comments (632) | Send Message
     
    This is really incredible and the last possibility of all the thinkables. Why comes this out so late ? Still full approval possible, I don't believe in 'negotiating'. Possible is approval for a few weeks use, but in that case many doctors will continue prescribe Northera off-label. What about approval dates in European and Asian countries ?
    14 Feb 2014, 07:44 PM Reply Like
  • Americanmade
    , contributor
    Comments (53) | Send Message
     
    I am moving on to a better stock, somebody ran the stock up this morning. More of the Dreamsupport team work. This site uses Dreamsupport advice and comments
    14 Feb 2014, 09:29 PM Reply Like
  • peterglit
    , contributor
    Comments (7) | Send Message
     
    This is a never ending story
    15 Feb 2014, 12:51 PM Reply Like
  • WalkTheTalk
    , contributor
    Comments (448) | Send Message
     
    LOL, let's pop a pipe dream and go wild until Monday..
    15 Feb 2014, 01:08 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (1267) | Send Message
     
    Stock is up sharply pre market--looking good folks!
    17 Feb 2014, 06:21 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (1267) | Send Message
     
    Chelsea is up sharply in pre-market trading--strap on your seat belt. Northera will get approved on Tuesday by the FDA.
    17 Feb 2014, 06:31 PM Reply Like
  • Grant Payne
    , contributor
    Comments (331) | Send Message
     
    Can I ask how you're getting your pre-market quote?
    17 Feb 2014, 07:04 PM Reply Like
  • PU600
    , contributor
    Comments (8) | Send Message
     
    http://cnb.cx/1hrCsiX
    18 Feb 2014, 06:11 AM Reply Like
  • Wolvesonashield
    , contributor
    Comments (2) | Send Message
     
    google finance also has pre-market quotes
    19 Feb 2014, 01:15 AM Reply Like
  • Grant Payne
    , contributor
    Comments (331) | Send Message
     
    Congrats all you longs. As for me, I messed up. Bought calls with a 9 dollar strike. They actually lost money. I guess I figured all biotechs usually double upon approval...
    19 Feb 2014, 12:06 PM Reply Like
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