Chelsea says no decision on Northera


Responding to the wild gyrations in its stock today, Chelsea Therapeutics (CHTP +2%) says no decision regarding Northera NDA has been received from the FDA as of late this morning.

SEC Form 8-K

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Comments (30)
  • P Man
    , contributor
    Comments (1511) | Send Message
     
    It's likely that every single person at CHTP is sitting around the fax machine, waiting for it to beep, hum and print. The FDA still faxes their decisions to the company. It's sort of an odd, yet extremely tense scene. Years of work and dollars spent are relying on what will spit out of a device invented in the 70s.
    14 Feb 2014, 01:10 PM Reply Like
  • 17208242
    , contributor
    Comments (25) | Send Message
     
    That would be about three or four people max :) lol
    17 Feb 2014, 10:24 AM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    Indeed. And some more info from the FDA wouldn't be bad.
    14 Feb 2014, 01:44 PM Reply Like
  • jim139220
    , contributor
    Comments (5) | Send Message
     
    delay is not good news for holders. we needed a clean approval
    14 Feb 2014, 01:47 PM Reply Like
  • BestPick
    , contributor
    Comments (235) | Send Message
     
    I disagree, DELAY news will be a GOOD sign. It's probably because they would have to see if the drug needs a restriction or no restriction, but the DELAY would mean the drug will pass.

     

    And it's also a good sign, as I comment on the comment box, because in a meantime, CHTP could recover from today's lost, and it will give more time for outsider investors to invest in the CHTP.
    14 Feb 2014, 02:04 PM Reply Like
  • 17208242
    , contributor
    Comments (25) | Send Message
     
    Who are we kidding here. I think it's pretty certain that if Northera is approved that it will have gobs of restrictions - it won't be a clean approval. Restrictions could be on length of treatment, requirements of follow up trials, etc. more importantly will be the response from Medicare on reimbursement due to the length of treatment restriction. The end result could be a killer on sales -again if it us approved. Cut your sales forecast by 3/4.
    17 Feb 2014, 12:21 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (2189) | Send Message
     
    One would think that there is some division on the panel; given that it's a Friday and it's Valentine's Day I was expecting early news.
    14 Feb 2014, 01:59 PM Reply Like
  • f5alcon
    , contributor
    Comments (697) | Send Message
     
    FDA opened late because of the weather
    14 Feb 2014, 02:00 PM Reply Like
  • emuziek
    , contributor
    Comments (30) | Send Message
     
    Paper jam on the Fax machine... Error message, "TP LOAD LETTER."
    Long $CHTP.
    14 Feb 2014, 02:23 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (2189) | Send Message
     
    The longer this stretches out I'm thinking that there will be an approval but there will be some type of stipulation attached to the approval.
    14 Feb 2014, 02:59 PM Reply Like
  • Hdrdr1999
    , contributor
    Comments (9) | Send Message
     
    Agree..
    14 Feb 2014, 04:36 PM Reply Like
  • emuziek
    , contributor
    Comments (30) | Send Message
     
    "PC LOAD LETTER" - is the error message.
    Been a while since I used a Fax machine.
    Recalling images from the movie, 'Office Space.'
    Ironic that high tech is tied to low tech device like a facsimile machine. - credit to P Man's comment above.

     

    Hurry up and wait.
    14 Feb 2014, 03:00 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (2189) | Send Message
     
    Didn't see your comment Forever before I wrote mine, but it appears that we are on the same page. The stock has dipped due to uncertainty. No news when many are expecting news will almost always give many the jitters.
    Northera will very likely get approval, the FDA is debating whether or not to attach a restriction of some type.
    14 Feb 2014, 03:11 PM Reply Like
  • 17208242
    , contributor
    Comments (25) | Send Message
     
    That's a wild guess. They could also be preparing a sensitive document for denial as well. I would not read into the delay. Government offices were closed due to the massive snow storm! There was a state of emergency issued. Everyone worked from home if they had power. Are you getting the picture on how bad the storm was.
    17 Feb 2014, 09:10 AM Reply Like
  • pawneeAl
    , contributor
    Comments (18) | Send Message
     
    My guess is the FDA is waiting for the market to close to avoid a massive gyration on Friday. And hope for an orderly opening on Monday.

     

    Being an optimist I think is is a good sign of acceptance!.
    14 Feb 2014, 03:34 PM Reply Like
  • terfa05
    , contributor
    Comments (2) | Send Message
     
    Feeling Fever!
    14 Feb 2014, 03:35 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (2189) | Send Message
     
    Good point pawneeAl. Since trading already got suspended once today on Chelsea--no need for craziness at the very end of the trading day.
    14 Feb 2014, 03:53 PM Reply Like
  • 17208242
    , contributor
    Comments (25) | Send Message
     
    The FDA does not make decisions based on the trading day.
    17 Feb 2014, 09:10 AM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (2189) | Send Message
     
    Deutsche says $8-9 on approval and pretty much 0 if Northera is denied.
    14 Feb 2014, 05:23 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (2189) | Send Message
     
    Just announced by the company:Due to severe weather leading to an office closure, the FDA will make its announcement on their next business day Tues. Feb 18, 2014.
    14 Feb 2014, 07:04 PM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    If approval with restriction, then many doctors will (continue) prescribing Northera off-label.
    14 Feb 2014, 08:32 PM Reply Like
  • 17208242
    , contributor
    Comments (25) | Send Message
     
    Doubt that
    17 Feb 2014, 09:00 AM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    "My guess is the FDA is waiting for the market to close to avoid a massive gyration on Friday. And hope for an orderly opening on Monday."

     

    Market is closed on Monday.
    14 Feb 2014, 09:06 PM Reply Like
  • Manitobatex
    , contributor
    Comments (1220) | Send Message
     
    FDA closed Friday due to weather.......

     

    Did you not read comments by *GreenGrowthGeek*......2 comments up........
    14 Feb 2014, 10:12 PM Reply Like
  • 17208242
    , contributor
    Comments (25) | Send Message
     
    Didn't any of you see the snow storm that the east coast was hit with? Schools closed and so we're government offices. State emergency! Most probably worked from home. A delay until Tuesday means nothing. On the negative side it could also mean that the FDA is crafting a delicate communication denying Northera's approval. After all it will be a sensitive denial due to the recommendation by the advisory committee. Personally I don't see how the FDA can approve Northera in light of not meeting the efficacy requirements for getting approval. It sets a bad president if they did and it would also question their decision on pulling Shire's midodrine. Shire could file suit. I saw mention of off label use of Northera. Are you kidding me! If Northera is approved, and that's a big IF, it will be with restrictions on use, and the FDA Will have this product buttoned tight. Off label use could jeopardize a conditional approval. Or even more realistic, there is absolutely no reason for Medicare to reimburse for off label use or for use beyond a week! I don't have any positions on CHTP but if I did it would probably lean to the short side.
    17 Feb 2014, 09:11 AM Reply Like
  • P Man
    , contributor
    Comments (1511) | Send Message
     
    The rules are different for orphan diseases. You're applying non-orphan logic here, which is inappropriate.
    17 Feb 2014, 09:08 PM Reply Like
  • 17208242
    , contributor
    Comments (25) | Send Message
     
    Oh, that's right, orphan drugs don't have to demonstrate efficacy! My bad.
    18 Feb 2014, 04:46 PM Reply Like
  • P Man
    , contributor
    Comments (1511) | Send Message
     
    The bar is far lower.
    18 Feb 2014, 04:52 PM Reply Like
  • P Man
    , contributor
    Comments (1511) | Send Message
     
    http://1.usa.gov/1e55I7t
    18 Feb 2014, 04:57 PM Reply Like
  • f5alcon
    , contributor
    Comments (697) | Send Message
     
    looks like it is approved http://bit.ly/1jOZf8K
    18 Feb 2014, 04:53 PM Reply Like
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