FDA Acknowledgement of Resubmission of NDA

[liane]

www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1870022&highlight=

MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA

VALENCIA, Calif.--(BUSINESS WIRE)--Oct. 30, 2013-- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. Its lead product candidate, AFREZZA®, has completed Phase 3 clinical trials. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

Source: MannKind Corporation

Company Contact:
MannKind Corporation
Matthew Pfeffer
Chief Financial Officer
661 775-5300
[e-mail]
or
Media Inquiries:
MCS Healthcare Public Relations
Laura De Zutter or Jeff Hoyak
800 477-9626
[e-mail]
[e-mail]

[hopetoretire]

Good news.  (better than bad) 

Plus: Anyone ever seen a PR agency listed as contact for media before this news release? 
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I will edit this and answer my own question - I see one other time - when they submitted NDA to FDA.  Wonder about significance. 

Media Inquiries:

MCS Healthcare Public Relations

Laura De Zutter or Jeff Hoyak

800 477-9626

[e-mail]

[e-mail]

[nemzter]

The countdown has begun!!!

@hope, I noticed that too when I saw the PR, they must be getting alot of inquiries about Afrezza, and I'm sure Matt is extremely busy working on negotiations.

[otherottawaguy]

Hope:

Someone over on Yahoo mentioned this is the same PR firm that Merck uses, is located on the opposite side of the country, and is divergent from the pattern of previous releases.

In the infamous words of yahoo's Itell "Interesting, Hmmmm..."

OOG

[raydonovan]

Does this further increase the chance that Summer Street Research Partners and Bart Classen are a real fraud?

www.streetinsider.com/Analyst+Comments/Mannkind+(MNKD)+Afrezza+NDA+Might+Not+Be+Accepted+-+Summer+Street/8727009.html

[babaoriley]

Hard to increase that chance, Ray! But perhaps they have.