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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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.
Dr Gabrielle Heathcote, vice chair of the CHC, expressed concerned that Ms Griffiths' response letter had not referred the council's concerns over what they considered to be "inadequacy and failures of the LHB's consultation process".
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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.
There has been no word from the White House in response to their letter.
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Four years later, I have yet to receive a response to my letter.
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But, as I pointed out on Today this morning, Mr Cameron's critics shouldn't over-reach either, in their response to the letter.
Andrew Dilnot's comments came in response to a letter from Labour accusing Prime Minister David Cameron of mixing the two up.
In response to one letter from Ickes expressing concern over DNC funds, Clinton suggested a direct mail campaign with a different message.
Taylor's response in the letter was abrupt, to say the least.
In response to the letter Mr Hunt criticised the trust's actions.
Now that the news is out, however, she said it had been a "great surprise" when Prince William's office contacted her husband Jack in response to a letter the couple had sent.
The eight mobile-phone companies that were asked collectively for data 1.3m times last year revealed that information by choice, in response to a letter from a congressman who was prompted to inquire by an article in the New York Times.
The memo sent Monday was in response to a letter from the state last month after New York City was one of few districts around the state that failed to meet a deadline to come up with a teacher evaluation system.
If Fifa's ethics committee gives weight to the Sunday Times claims by getting tough with the two members currently suspended and there is a good response to the letter and the inspection report, then England may feel they can still get back into the race.
Mr. Bauer's response was a second letter to Justice calling for the prosecution of Mr. Simmons.
Havana's response came in a letter sent this month to the EU headquarters in Brussels, the agency reported.
But in a terse letter in response, the LEP chairmen reject the criticism.
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No public statement has ever been provided by the SEC, and, likewise, there was no response to the USCIRF letter of inquiry.
The court has been told that Mr James wrote a letter in response to Mrs Thompson's criticism of the council following the incident.
Blumenthal is also awaiting a response to his original letter dated May 27 which sought further information about unauthorized data collected in Connecticut towns and cities.
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Security Council members were divided over Iraq's initial response: The Iraqi letter was welcomed by France, Russia and China as the council began meeting late Saturday.
My original response to the FunnyJunk letter was probably humiliating, and following your comments, I gather that you allegedly received a slew of nasty emails and phone calls.
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Mr. Gingrich's letter in response was dated December 8, 1994.
Mr Davies published a letter in response expressing his sympathy and the willingness of the Welsh government to consider any practical suggestions farmers' leaders may have to alleviate the situation.
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He did get a response, a form letter rejection.
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After Markel's findings were published in the Journal of the American Medical Association, Barry wrote a letter in response, saying it wasn't swift action but rather an earlier wave of mild flu, acting like a vaccination, that was probably responsible for New York's relatively low caseload.
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