Comments on: FDA & Pharma: What’s A Deadline Among Friends? http://www.pharmalot.com/2008/10/fda-pharma-whats-a-deadline-among-friends/ News, Comment and Conversation Fri, 10 Feb 2012 21:20:16 +0000 http://wordpress.org/?v=2.6.2 By: Ed Silverman http://www.pharmalot.com/2008/10/fda-pharma-whats-a-deadline-among-friends/#comment-379494 Ed Silverman Tue, 28 Oct 2008 16:04:37 +0000 http://www.pharmalot.com/?p=16686#comment-379494 Hi Anon2, Thanks for pointing that out. Like any list of this sort, comprehensiveness can be hard to achieve. If anyone else has another drug to add, please do so. Regards ed Hi Anon2,

Thanks for pointing that out. Like any list of this sort, comprehensiveness can be hard to achieve. If anyone else has another drug to add, please do so.

Regards
ed

]]> By: Anon2 http://www.pharmalot.com/2008/10/fda-pharma-whats-a-deadline-among-friends/#comment-379489 Anon2 Tue, 28 Oct 2008 15:10:54 +0000 http://www.pharmalot.com/?p=16686#comment-379489 And what about Roche's March 2007 sNDA for Xeloda (for use with Eloxatin in the XELOX regimen), which was last mentioned publicly by Roche in December 2007, only to have disappeared from the news? The PDUFA date should have been January 25, 2008. And what about Roche’s March 2007 sNDA for Xeloda (for use with Eloxatin in the XELOX regimen), which was last mentioned publicly by Roche in December 2007, only to have disappeared from the news? The PDUFA date should have been January 25, 2008.

]]> By: Anon http://www.pharmalot.com/2008/10/fda-pharma-whats-a-deadline-among-friends/#comment-378393 Anon Fri, 17 Oct 2008 20:38:36 +0000 http://www.pharmalot.com/?p=16686#comment-378393 Let's not forget Asenapine. Schering Plough announced that it was filed just after Thanksgiving last year. This means that it was submitted no later than early October last year and more likely several weeks earlier. Thus over a year has passed since it was submitted. Since the review clock is 10 months this means that the letter should have been sent a few months ago. Schering Plough needs asenapine to make up for all the lost sales from Vytorin not only to replace lost income but its income stream is also needed to fund the drugs in the development pipeline. SP is not in good situation and no news is NOT good news. Looks like more difficulties for SP and its stock price. Let’s not forget Asenapine. Schering Plough announced that it was filed just after Thanksgiving last year. This means that it was submitted no later than early October last year and more likely several weeks earlier. Thus over a year has passed since it was submitted. Since the review clock is 10 months this means that the letter should have been sent a few months ago.

Schering Plough needs asenapine to make up for all the lost sales from Vytorin not only to replace lost income but its income stream is also needed to fund the drugs in the development pipeline.

SP is not in good situation and no news is NOT good news. Looks like more difficulties for SP and its stock price.

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