t**u 发帖数: 1572 | 1 http://finance.yahoo.com/news/Transcept-Pharmaceuticals-prnews-
其实这个安眠药会影响第二天开车,
Press Release Source: Transcept Pharmaceuticals, Inc. On Tuesday July 12,
2011, 8:02 pm EDT
POINT RICHMOND, Calif., July 12, 2011 /PRNewswire/ -- Transcept
Pharmaceuticals, Inc. (Nasdaq:TSPT - News) announced today that it expects
to receive a Complete Response Letter from the U.S. Food and Drug
Administration (FDA) regarding the resubmitted New Drug Application (NDA)
for Intermezzo® (zolpidem tartrate sublingual tablet) on or before July
14, 2011, the PDUFA date assigned by the FDA for completion of the
Intermezzo® NDA review. The FDA issues a Complete Response Letter to
indicate that the review cycle for an NDA is complete and that the
application is not ready for approval. The Intermezzo® NDA seeks
approval to market Intermezzo® for use as needed for the treatment of
insomnia when a middle of the night awakening is followed by difficulty
returning to sleep.
This update from Transcept is based on a teleconference with the FDA held
earlier today during which the FDA expressed continued concerns about the
safety profile of Intermezzo® based on information in the resubmitted
NDA. Until Transcept receives the anticipated Complete Response Letter, the
company has limited information as to the full extent of FDA concerns.
After the Complete Response Letter is received, Transcept will announce
additional information on the content of the letter and the company's plans
for the future regulatory development of Intermezzo®. | K********g 发帖数: 9389 | 2 从来都没看好过,这种二进宫的,基本面也差的,没啥好货色。
July
【在 t**u 的大作中提到】 : http://finance.yahoo.com/news/Transcept-Pharmaceuticals-prnews- : 其实这个安眠药会影响第二天开车, : Press Release Source: Transcept Pharmaceuticals, Inc. On Tuesday July 12, : 2011, 8:02 pm EDT : POINT RICHMOND, Calif., July 12, 2011 /PRNewswire/ -- Transcept : Pharmaceuticals, Inc. (Nasdaq:TSPT - News) announced today that it expects : to receive a Complete Response Letter from the U.S. Food and Drug : Administration (FDA) regarding the resubmitted New Drug Application (NDA) : for Intermezzo® (zolpidem tartrate sublingual tablet) on or before July : 14, 2011, the PDUFA date assigned by the FDA for completion of the
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