Count on at least another 1.5 years

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Anonymous

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This is no ordinary delay. The FDA is requesting an additional study and this will take time and money in addition to other hold ups. There is absolutely no way a new company like this would be able to keep all the managers they hired for that long. Obviously, they will all start to find other opportunities if they are smart.
 

Anonymous said:
You have no idea what you are talking about. The FDA has not met with Chelsea management yet to outline what is needed. Go spread your lies somewhere else.
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I am sorry, but you are delusional. Nothing moves that fast and THEY do want another study especially since it will be highlighted with a black box warning. No lies just reality.
 
Anonymous said:
The ongoing study will be done in a few weeks...
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READ THis and SHUT THE FUCK UP-STUPID


Chelsea Therapeutics International Ltd. (CHTP) fell as much as 29 percent after failing to get the U.S. regulatory approval needed to bring its first drug to market.

The Food and Drug Administration wants more data on Northera, a medicine intended to treat a cause of dizziness and fainting in people with nervous-system disorders, Chelsea said in a statement yesterday. Chelsea tumbled 29 percent to $2.62 at the close in New York, the biggest single-day decline since Feb. 13.

The FDA requested information from an additional study of Northera, which can curb drops in blood pressure, Chelsea said. The Charlotte, North Carolina-based company said it’s conducting a clinical trial that may provide the additional data about the drug’s “efficacy and durability” sought by the FDA.

The trial “may not be sufficient for approval” because the FDA is likely to ask for more information about a range of symptoms instead of measuring only a decrease in falls, Robyn Karnauskas, an analyst with Deutsche Bank Securities in New York. wrote in a note to clients today.

Another trial may cause a two-year delay and lead to a late 2014 product introduction,
 
Finally a great post! Thank you for sharing. Everyone needs to WAKE UP. This is a deadend and you need to find something else!




QUOTE=Anonymous;4314983]READ THis and SHUT THE FUCK UP-STUPID


Chelsea Therapeutics International Ltd. (CHTP) fell as much as 29 percent after failing to get the U.S. regulatory approval needed to bring its first drug to market.

The Food and Drug Administration wants more data on Northera, a medicine intended to treat a cause of dizziness and fainting in people with nervous-system disorders, Chelsea said in a statement yesterday. Chelsea tumbled 29 percent to $2.62 at the close in New York, the biggest single-day decline since Feb. 13.

The FDA requested information from an additional study of Northera, which can curb drops in blood pressure, Chelsea said. The Charlotte, North Carolina-based company said it’s conducting a clinical trial that may provide the additional data about the drug’s “efficacy and durability” sought by the FDA.

The trial “may not be sufficient for approval” because the FDA is likely to ask for more information about a range of symptoms instead of measuring only a decrease in falls, Robyn Karnauskas, an analyst with Deutsche Bank Securities in New York. wrote in a note to clients today.

Another trial may cause a two-year delay and lead to a late 2014 product introduction,[/QUOTE]
 
Anonymous said:
would they still honor the same choices?? that is all i want to know? In six months can i still get the same car? Will the terriotires change??
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Stop being a trouble maker and throwing salt in the wound. Everyone knows nothing will happen as soon as 6 months. Haven't you read any of the articles? In addition, this was a start up company and they have no money for fleet vehicles. This opportunity isn't going to happen. Simple as that.
 


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