http://www.pharmalot.com/2009/12/fda-complete-response-letters-transparency/ News, Comment and Conversation Fri, 10 Feb 2012 20:18:00 +0000 http://wordpress.org/?v=2.6.2 http://www.pharmalot.com/2009/12/fda-complete-response-letters-transparency/#comment-596675 Geoff Tue, 11 Jan 2011 17:45:45 +0000 http://www.pharmalot.com/?p=20351#comment-596675 Sorry, I agree with Pharmalot. Pharma companies use the secrecy of the CRL's to abuse investors and mislead them as to the true contents of them. Companies then raise capital after misleading the investors. Without investors, as (I can tell Pharmavet clearly hates them, he is just sadly mistaken to their true value though because it appears he doens't understand capital markets very well), but the fact remains that almost no new drugs would make it to market because nobody would take the risk to develop a new drug if there were not a payout at the end, ie. why we need investors (who take the risk), welcome to capitalism. Too bad for pharma companies. If they hadn't abused the process then this might not be an issue, but they have abused the secrecy granted to them. Finally, the FDA is a government agency, seeing transparency into why some snakeoil drug got denied is 100% completely reasonable. Pharmavet, trade secrets are protected by patents, so sorry there goes your whole argument right out the window. Sorry, I agree with Pharmalot. Pharma companies use the secrecy of the CRL’s to abuse investors and mislead them as to the true contents of them. Companies then raise capital after misleading the investors. Without investors, as (I can tell Pharmavet clearly hates them, he is just sadly mistaken to their true value though because it appears he doens’t understand capital markets very well), but the fact remains that almost no new drugs would make it to market because nobody would take the risk to develop a new drug if there were not a payout at the end, ie. why we need investors (who take the risk), welcome to capitalism. Too bad for pharma companies. If they hadn’t abused the process then this might not be an issue, but they have abused the secrecy granted to them. Finally, the FDA is a government agency, seeing transparency into why some snakeoil drug got denied is 100% completely reasonable. Pharmavet, trade secrets are protected by patents, so sorry there goes your whole argument right out the window.

]]> http://www.pharmalot.com/2009/12/fda-complete-response-letters-transparency/#comment-450948 pharmavet Fri, 11 Dec 2009 17:17:20 +0000 http://www.pharmalot.com/?p=20351#comment-450948 I disagree with Nissen. Complete response letters are the new "approvable" letters and usually contain very specific instructions to the Sponsor as to which additional studies, data, etc are necessary for final approval. This information should be considered proprietary for obvious competitive reasons. These letters usually contain little of public health value. The only ones to benefit from disclosure would be stock speculators. I disagree with Nissen. Complete response letters are the new “approvable” letters and usually contain very specific instructions to the Sponsor as to which additional studies, data, etc are necessary for final approval. This information should be considered proprietary for obvious competitive reasons. These letters usually contain little of public health value. The only ones to benefit from disclosure would be stock speculators.

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