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Post by bion61 on Oct 14, 2013 0:39:33 GMT -5
Well, we filed today now we wait and wait....
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Filing
Oct 14, 2013 4:30:00 GMT -5
Post by liane on Oct 14, 2013 4:30:00 GMT -5
bion,
Where did you see that? I don't see any official notice that they filed yet.
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Post by liane on Oct 14, 2013 5:09:42 GMT -5
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Filing
Oct 14, 2013 8:00:03 GMT -5
Post by rak5555 on Oct 14, 2013 8:00:03 GMT -5
How many days does the FDA have within which to accept or decline the submission? In my experience, the acceptance announcement has more upside than the filing.
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Filing
Oct 14, 2013 8:00:03 GMT -5
Post by Earl Grey on Oct 14, 2013 8:00:03 GMT -5
MannKind Corporation (MNKD) today announced the resubmission on October 13, 2013 of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AFREZZA® (insulin human [rDNA origin]) Inhalation Powder with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. The resubmission is based on the entire data set from the extensive AFREZZA clinical development program and particularly the positive results from two recent Phase 3 trials, one in patients with type 1 diabetes (study 171) and one in patients with type 2 diabetes (study 175). “We designed the recent studies with input and guidance from the FDA, and both achieved their primary efficacy endpoints and safety objectives,” said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “I am very proud of our team for completing an extensive submission on a very ambitious schedule. We will continue to work with the FDA to bring AFREZZA to market for the millions of diabetes patients in the United States who might benefit from this novel product.” finance.yahoo.com/news/mannkind-resubmits-drug-application-u-100000321.html
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Filing
Oct 14, 2013 8:03:49 GMT -5
Post by liane on Oct 14, 2013 8:03:49 GMT -5
rak,
FDA has 14 days. Don't know if they could respond sooner. The NDA was filed on 10/13 - which is Sunday. So I also don't know how that will impact the actual reply from FDA - Fri 10/25 or Mon 10/28.
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Post by bion61 on Oct 14, 2013 8:57:18 GMT -5
Liane,
Yes Al was very pleased and said we now have 6 months. And it looks like a pain med is next then joked about Viagra, but it didn't feel like a joke.
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Filing
Oct 14, 2013 8:59:38 GMT -5
Post by liane on Oct 14, 2013 8:59:38 GMT -5
Thanks for the report bion! Your post was a full 3-4 h before anything hit the wires!
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Post by brentie on Oct 14, 2013 9:21:46 GMT -5
rak, FDA has 14 days. Don't know if they could respond sooner. The NDA was filed on 10/13 - which is Sunday. So I also don't know how that will impact the actual reply from FDA - Fri 10/25 or Mon 10/28. Liane, the FDA may have 14 days but don't be too disappointed if it takes them a little longer. They should be called the FDELAY, they were late on both of MNKD"s PDUFA's. MNKD submitted the original NDA on March 16, 2009 and the FDA didn't accept it until May 18, 2009. www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-news&nyo=4I believe the next resubmission was on June 29, 2010 and it was accepted on July 20, 2010. www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-news&nyo=3
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Filing
Oct 14, 2013 11:31:39 GMT -5
Post by liane on Oct 14, 2013 11:31:39 GMT -5
brentie, True, the FDA often disappoints, but I do think in recent years there has been a push for transparency on the timelimes. It took me all morning, but i finally found a document pointing to the 2 week timeline to accept the NDA. www.fda.gov/downloads/Drugs/.../Guidances/ucm079303.pdf
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Filing
Oct 14, 2013 11:42:07 GMT -5
Post by brentie on Oct 14, 2013 11:42:07 GMT -5
brentie, True, the FDA often disappoints, but I do think in recent years there has been a push for transparency on the timelimes. It took me all morning, but i finally found a document pointing to the 2 week timeline to accept the NDA. www.fda.gov/downloads/Drugs/.../Guidances/ucm079303.pdfGood detective work, Liane. It would be nice if they were on time for once. We'll have to wait and see. Thanks for the link.
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Filing
Oct 14, 2013 11:42:49 GMT -5
Post by goyocafe on Oct 14, 2013 11:42:49 GMT -5
The FDA may have a unique relationship with MNKD at this stage of the game. We won't ever know until it happens (if it happens), but with the colored past, maybe the FDA is going to play "nice" for once with us and move this along quickly.
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Filing
Oct 14, 2013 12:09:19 GMT -5
Post by BD on Oct 14, 2013 12:09:19 GMT -5
Just what I was thinking, Homer...er, goyo (A high school buddy of mine from L.A. is the music editor on The Simpsons... talk about falling into a good long-term gig!)
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Filing
Oct 14, 2013 13:00:15 GMT -5
Post by liane on Oct 14, 2013 13:00:15 GMT -5
Here's a more recent (10/1/12) document on the NDA refiling timeline: www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm073490.htmSection VII, G: If the resubmission is complete: Ensure the review clock was started upon receipt once the review team confirms that the resubmission is complete and the designation of “response to CR letter” is selected in the regulatory database. [RPM] Determine initially whether or not the amendment is a Class 1 or Class 2 Resubmission if the applicant indicates a complete response for a PDUFA application or efficacy supplement. Note: Class 1 or Class 2 designations do not apply to: manufacturing or labeling supplements, non user fee or biosimilar biuological products. [RPM] Confirm Class 1 or Class 2 category if the resubmission responds completely to an action letter for a PDUFA application or efficacy supplement. [Review Committee Members] Send a Resubmission Acknowledgement Letter for an original application within 14 calendar days of receipt and for efficacy supplements within 30 days of receipt, as resources permit, indicating the new action due date to the applicant. [RPM] Acknowledge a resubmission for a labeling or manufacturing supplement by telecon, email, or letter. [RPM]
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Filing
Oct 14, 2013 15:58:51 GMT -5
Post by babaoriley on Oct 14, 2013 15:58:51 GMT -5
"as resources permit" - no hard date, so we'll just have to wait and see. It's just more noise anyway, partnership or PDUFA date, and hopefully it will be the first, followed by success in the second. Those are what matters.
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