The FDA issued the first complete response letter rejecting the sNDA last June.
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We continue to believe that the FDA is highly likely to issue a second Complete Response Letter to MannKind.
The initial complete response letter, which was issued in the spring of 2010, cited risk management and manufacturing issues.
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Increasingly we get our mail messages on our mobile devices without the time, attention or full-size keyboard to make a complete response.
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The FDA had initially declined to approve Zioptan, sending Merck a "complete response" letter in November asking for more information about the new drug application.
Reader and Arena Pharmaceuticals investor Charlie Brothers e-mailed me with this question today in response to my Arena post on one sentence in the complete response letter.
According to the companies, the FDA sent a complete response letter regarding the trial-stage drug Horizant, which is in the form of an extended-release pill taken to lessen pain caused by the condition.
Well, any biotechnology investor would, because the standard practice in the biotech industry is not to reveal the rejection letters, called Complete Response Letters, in which the Food and Drug Administration spells out why it is not approving a drug and what questions it needs answered before it will reconsider.
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If you look at patients who get a complete cytogenetic response as their best response in the Iris trial, their risk of ever progressing in the next 4 years, so about 48 months roughly, is about 8% overall.
The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months.
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White House spokesman Scott McClellan said Tuesday that he would not provide "a play-by-play analysis" until a White House review of the Katrina response was complete.
And I think that makes complete sense as a response to some of the artists that we have shown, who, you know, make huge installation projects full of meat - that then rots.
In fact, he only agreed to an interview with CNN after a number of conversations that involved middle men, telephone calls with ever changing numbers and, finally, a cloak and dagger meeting complete with a secret phrase and response.
Such openness is in complete contrast to Saudi Arabia's original response to the problem, which was for many years to try to cover it up or blame it on foreigners.
It has been uneven and it is far from complete, but it is a picture of a response to a financial and economic crisis that I think bears review.
"From the press reports, it would appear that the police have prematurely accused the pilots in response to public pressure and have not conducted a complete and thorough investigation of the facts, " Joel R Weiss wrote in an email quoted by the AP news agency.
We then started to incorporate the online outreach and response experience in our day to day operations to offer more complete marketing solutions (from consumer responses to e-mail signatures).
Strategy was being co-ordinated across Whitehall, she added, while the proposed new National Crime Agency would, for the first time, "pull together the complete intelligence picture" and work with the police and other law enforcement agencies to co-ordinate a national response.
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