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Post by savzak on Apr 7, 2014 8:12:59 GMT -5
I'm looking for theories. Any and all are welcome. Long theories, short theories, whatever. Please offer any reasonable speculation regarding why the delay needs to be so long. Why do they need 3 months?
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Post by jpg on Apr 7, 2014 8:16:43 GMT -5
In FDA land 3 months is not a big delay... Look at some of their past delays and we are almost lucky. Not that I am in any way happy about this. I think the FDA is a danger to innovation.
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Post by notamnkdmillionaire on Apr 7, 2014 8:28:34 GMT -5
In FDA land 3 months is not a big delay... Look at some of their past delays and we are almost lucky. Not that I am in any way happy about this. I think the FDA is a danger to innovation. True, Zogenix's Zohydro was delayed ~ a year before the controversial approval by the fda after a almost unanimous denial by the Adcomm. Hopefully, this delay is all about the labeling and post market studies. |
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Post by rockyp on Apr 7, 2014 8:29:16 GMT -5
It is curious to me why the delay is so large, given that the FDA was the one that scheduled the AdCom two weeks before the PDUFA. One would have thought they knew how much time they needed post-AdCom.
Here are two theories:
1) When the FDA reviewers first looked at the data back in August their take was that the data did not support approval. However, wanting to be sure, they scheduled an AdCom. Since the FDA was expecting the committee to recommend against approval, they figured they only needed two weeks post-AdCom to rubber stamp the rejection. When the AdCom overwhelmingly supported the drug, the FDA realized that they needed to address issues like labeling, follow-on study parameters, etc., on their way to finally approving Afrezza.
2) The FDA is determined to reject the drug. They thought they would get a No Vote from the AdCom or at best a 50-50 vote which would allow them to reject the drug within two weeks of the AdCom. In light of the positive vote received at AdCom, the FDA requires more time to justify their rejection.
I tend to subscribe to the first theory.
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Post by esstan2001 on Apr 7, 2014 8:32:10 GMT -5
jpg-
Al Mann in so much as told the FDA this right to Peggy Hamburg's face (there is a 4-5 year old youtube clip of a 56+ minute presentation from a panel discussion about the FDA drug approval process)
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Post by esstan2001 on Apr 7, 2014 8:34:15 GMT -5
rockyp- I vote for reason 1) also :-)
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Post by Deleted on Apr 7, 2014 11:56:06 GMT -5
jpg“Bureaucracy is the death of all sound work.” ― Albert Einstein
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Post by 4allthemarbles on Apr 7, 2014 12:47:54 GMT -5
jpg“Bureaucracy is the death of all sound work.” ― Albert Einstein Amen. |
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Post by savzak on Apr 7, 2014 13:15:21 GMT -5
jpg“Bureaucracy is the death of all sound work.” ― Albert Einstein “Nothing distinguishes more clearly conditions in a free country from those in a country under arbitrary government than the observance in the former of the great principles known as the Rule of Law. Stripped of all technicalities, this means that government in all its actions is bound by rules fixed and announced beforehand – rules which make it possible to foresee with fair certainty how the authority will use its coercive power in given circumstances and to plan one’s individuals affairs on the basis of this knowledge. Though this ideal can never be perfectly achieved, since legislators as well as those to whom the administration of the law is entrusted are fallible men, the essential point, that the direction left to the executive organs wielding coercive power should be reduced as much as possible, is clear enough. While every law restricts individual freedom to some extent by altering the means which people may use in the pursuit of their aims, under the Rule of Law the government is prevented from stultifying individual efforts by ad hoc action. Within the known rules of the game the individual is free to pursue his personal ends and desires, certain that the powers of government will not be used deliberately to frustrate his efforts.”
-Friedrich Hayek; The Road to Serfdom
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Post by babaoriley on Apr 7, 2014 18:59:05 GMT -5
I'm looking for theories. Any and all are welcome. Long theories, short theories, whatever. Please offer any reasonable speculation regarding why the delay needs to be so long. Why do they need 3 months? Check out this recent PDUFA date extension for Delcath: " NEW YORK, NY - April 8, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) goal date for its review of the Company's New Drug Application (NDA) for the marketing approval of MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), the Company's proprietary drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver. On March 18, 2013 the Company supplied certain information in response to an FDA request. The information related to clarification regarding the bridging studies that were performed between the filter generations that were used throughout the development program. As the information was requested and supplied within 90 days of the June 15, 2013 PDUFA goal date, the agency exercised its option to extend the PDUFA goal date to provide adequate time for completion of its review. The three-month extension to September 13, 2013 is the standard extension cycle granted. The previously announced Oncologic Drugs Advisory Committee (ODAC) meeting remains unchanged, and the FDA will convene its ODAC Panel on Thursday, May 2, 2013 for review of the Company's NDA. " My memory from quite a while ago was telling me that three months was the longest the FDA could "extend" without "vacating" the PDUFA date and putting it out somewhere into the 10 month realm. After reading some stuff, I think in fact, the three month (more precisely 90 days) period relates to when the additional material data is received by the FDA. |
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Post by babaoriley on Apr 7, 2014 19:16:29 GMT -5
I'm looking for theories. Any and all are welcome. Long theories, short theories, whatever. Please offer any reasonable speculation regarding why the delay needs to be so long. Why do they need 3 months? Check out this recent PDUFA date extension for Delcath: "NEW YORK, NY - April 8, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) goal date for its review of the Company's New Drug Application (NDA) for the marketing approval of MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), the Company's proprietary drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver. On March 18, 2013 the Company supplied certain information in response to an FDA request. The information related to clarification regarding the bridging studies that were performed between the filter generations that were used throughout the development program. As the information was requested and supplied within 90 days of the June 15, 2013 PDUFA goal date, the agency exercised its option to extend the PDUFA goal date to provide adequate time for completion of its review. The three-month extension to September 13, 2013 is the standard extension cycle granted. The previously announced Oncologic Drugs Advisory Committee (ODAC) meeting remains unchanged, and the FDA will convene its ODAC Panel on Thursday, May 2, 2013 for review of the Company's NDA. " Here's another for Biogen Idec (a bit different, as that indicates the agency has not asked for additional studies, it would be nice to be able to have that confirmed by MNKD): "WESTON, Mass.--(BUSINESS WIRE)--Oct 18, 2012 - Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the company's oral therapeutic candidate for the treatment of multiple sclerosis (MS). The 3 month extension is a standard extension period. The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies." My memory from quite a while ago was telling me that three months was the longest the FDA could "extend" without "vacating" the PDUFA date and putting it out somewhere into the 10 month realm. After reading some stuff, I think in fact, the three month (more precisely 90 days) period relates to when the additional material data is received by the FDA. |
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Post by goyocafe on Apr 7, 2014 19:37:00 GMT -5
I'm looking for theories. Any and all are welcome. Long theories, short theories, whatever. Please offer any reasonable speculation regarding why the delay needs to be so long. Why do they need 3 months? Check out this recent PDUFA date extension for Delcath: " NEW YORK, NY - April 8, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) goal date for its review of the Company's New Drug Application (NDA) for the marketing approval of MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), the Company's proprietary drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver. On March 18, 2013 the Company supplied certain information in response to an FDA request. The information related to clarification regarding the bridging studies that were performed between the filter generations that were used throughout the development program. As the information was requested and supplied within 90 days of the June 15, 2013 PDUFA goal date, the agency exercised its option to extend the PDUFA goal date to provide adequate time for completion of its review. The three-month extension to September 13, 2013 is the standard extension cycle granted. The previously announced Oncologic Drugs Advisory Committee (ODAC) meeting remains unchanged, and the FDA will convene its ODAC Panel on Thursday, May 2, 2013 for review of the Company's NDA. " My memory from quite a while ago was telling me that three months was the longest the FDA could "extend" without "vacating" the PDUFA date and putting it out somewhere into the 10 month realm. After reading some stuff, I think in fact, the three month (more precisely 90 days) period relates to when the additional material data is received by the FDA. I'd welcome that level of detail in the release from this morning. At least we'd get a sense of what specifically caused the delay. |
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Post by babaoriley on Apr 7, 2014 21:18:34 GMT -5
www.docstoc.com/docs/83537454/CDER-21st-Century-Review-Desk-Reference-GuideCheck out pages 42-46. Seems as though additional information should have been requested by the FDA at the mid term review meeting, five months into the process, so assuming MNKD responded with additional within the last three months (after Jan 15, 2014), then the FDA could actually push the thing into the next review period, which they did not do, they kept the AdCom hearing as is, and only moved the PDUFA date the standard 3 month period, which means the FDA felt that whatever it was they were asking about should be able to be addressed within that time frame. But I still don't know if whatever MNKD did provide to them, was taken into account by the staff in preparing for the AdCom hearing, and, consequently, whether AdCom can be said to have weighed in on the effect of the additional information. I apologize if this kind of stuff has already been posted today, I haven't had the time to catch up on many of the posts.
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