thefranchise...your statement that SOMX looked "terrible" compared to TSPT and TSPT got denied? SOMX knows clearly what is expected of them and had met with the FDA in January to discuss their data and what they need to do. If it gets approved great but if not it isn't for the lack of reason you stated which is because the data looks "terrible." Again...the only thing I ask...is that if you feel the need to make "blanket" statement regarding any company we discuss on this thread then back it up with data and put out a strong & logical post. If you can't back them up with clinical data, especially when dealing with biotechs, then don't post it. Good luck! Thanks, $heff
TSPT..reviewing the conversation between TSPT management and the FDA there are many issues at hand that has caused the management team to have to resubmit an application.
As previously announced, the FDA stated in the CRL that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo® in the as-needed treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. However, the FDA indicated that the intended use of Intermezzo® in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established, and that the Intermezzo® NDA could not be approved in its present form.
The FDA further recognized that the Intermezzo® data submitted by Transcept did not indicate next day residual effects significantly different from placebo. However, the FDA requested additional data demonstrating that Intermezzo®, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability.
The FDA expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects, with particular reference to next day driving ability. Specifically, the FDA asked Transcept to address methods to avoid inadvertent dosing with less than four hours of bedtime remaining and inadvertent re-dosing in a single night.
Reading the January 21,2010 Press Release shows that both management @ SOMX and the FDA have a clear understanding of what to expect March 21,2010. The FDA also met with SOMX on Jan 25th and told them that ther resubmission of their packet would suffice
Somaxon held a meeting with senior leadership at the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the issues raised by the FDA in the Complete Response Letter Somaxon received in December 2009 relating to the Silenor NDA. The only remaining efficacy issue was related to the robustness of sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. In the meeting, the FDA and the company discussed this issue, and the agency instructed Somaxon to resubmit the contents of its January 20, 2010 pre-meeting briefing package to the FDA. The agency acknowledged that this resubmission would be considered a complete response to the Complete Response Letter Somaxon received in December. The FDA also agreed that this would be considered a Class 1 resubmission with a two-month review cycle. No additional safety or efficacy data was required to be included in the resubmission, and the company filed the resubmission with the FDA on January 21, 2010. As a result, the company anticipates a decision from the FDA by March 21, 2010.
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I agree every agent is different, but I think looking historically at the FDAs hard stance on sleep medication can't be ignored. I personally thought SOMX looked terrible compared to TSPT, and TSPT got denied. I wish every best of luck on it, and hope most got in around the alert so they can claim a profit here soon. I just wouldn't hold into approval. Hopefully it does get approved and everyone gets rich ;)
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