Amylin制药公司贸易行动因FDA顾问团会议迫近的消息而中
WASHINGTON (Reuters Health) - Trading of shares in San Diego, California-based Amylin Pharmaceuticals was halted on Wednesday after they plunged almost 25% in pre-market trade after documents panning its diabetes candidate Symlin appeared on the US Food and Drug Administration's (FDA) Web site.
The comments were posted to prepare an FDA advisory committee for a meeting on Thursday at which its members are to debate whether the agency should approve the drug. Instead, the documents acted as a warning to investors that the synthetic analog, known generically as pramlintide acetate, would not be endorsed.
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In the documents, FDA reviewer Dr. Robert Misbin noted that while Symlin appears to briefly reduce excessive levels of glucose, it might push levels too low over the long term in a number of patients.
"Particularly alarming is the number of patients that had life-altering events on pramlintide related to hypoglycemia," Misbin wrote.
Misbin also said the company poorly conducted clinical trials, which provided little insight into which patients would benefit from Symlin.
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However, some analysts maintained that Misbin's views do not necessarily reflect those of the FDA as a whole or what might occur at Thursday's advisory meeting.
WHISTLE-BLOWER AND MALCONTENT
Misbin is more widely recognized as the FDA reviewer who played a key role in the controversial withdrawal of the diabetes drug Rezulin (troglitazone).
"This guy is an FDA whistle-blower, a malcontent," Lehman Brothers analyst Rachel Leheny, who has maintained a buy rating on Amylin Pharmaceuticals, told Reuters.
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Indeed, there is little chance that this drug will receive an approval recommendation, said Ira Loss, a healthcare analyst from Washington Analysis.
First, the data released last week was inconclusive, Loss told Reuters Health. Moreover, the documents posted on the FDA Web site revealed that the company basically ignored specific advise from the agency on how to design its clinical trials, Loss said.
Loss added that it also would not behoove investors to ignore Misbin's comments solely due to his whistle-blower reputation.
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"I think he will certainly be listened to," Loss told Reuters Health. "He has friends in high political places."
In a statement, Amylin said it believed the results were compelling and supported the approval of their drug.
Shares of the company, which are listed on the NASDAQ exchange, closed at $7.75 on Tuesday before falling to $5.97 pre-opening trading on an electronic exchange., 百拇医药
The comments were posted to prepare an FDA advisory committee for a meeting on Thursday at which its members are to debate whether the agency should approve the drug. Instead, the documents acted as a warning to investors that the synthetic analog, known generically as pramlintide acetate, would not be endorsed.
, 百拇医药
In the documents, FDA reviewer Dr. Robert Misbin noted that while Symlin appears to briefly reduce excessive levels of glucose, it might push levels too low over the long term in a number of patients.
"Particularly alarming is the number of patients that had life-altering events on pramlintide related to hypoglycemia," Misbin wrote.
Misbin also said the company poorly conducted clinical trials, which provided little insight into which patients would benefit from Symlin.
, 百拇医药
However, some analysts maintained that Misbin's views do not necessarily reflect those of the FDA as a whole or what might occur at Thursday's advisory meeting.
WHISTLE-BLOWER AND MALCONTENT
Misbin is more widely recognized as the FDA reviewer who played a key role in the controversial withdrawal of the diabetes drug Rezulin (troglitazone).
"This guy is an FDA whistle-blower, a malcontent," Lehman Brothers analyst Rachel Leheny, who has maintained a buy rating on Amylin Pharmaceuticals, told Reuters.
, 百拇医药
Indeed, there is little chance that this drug will receive an approval recommendation, said Ira Loss, a healthcare analyst from Washington Analysis.
First, the data released last week was inconclusive, Loss told Reuters Health. Moreover, the documents posted on the FDA Web site revealed that the company basically ignored specific advise from the agency on how to design its clinical trials, Loss said.
Loss added that it also would not behoove investors to ignore Misbin's comments solely due to his whistle-blower reputation.
, http://www.100md.com
"I think he will certainly be listened to," Loss told Reuters Health. "He has friends in high political places."
In a statement, Amylin said it believed the results were compelling and supported the approval of their drug.
Shares of the company, which are listed on the NASDAQ exchange, closed at $7.75 on Tuesday before falling to $5.97 pre-opening trading on an electronic exchange., 百拇医药