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Post by slushy on Oct 7, 2013 9:04:16 GMT -5
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Post by StevieRay on Oct 7, 2013 10:09:28 GMT -5
According to the PharmExecBlog the FDA is on "hold" and is not accepting NDA submissions until authorized by congress. blog.pharmexec.com/2013/10/01/government-shutdown-halts-fda-product-submissions/Just another wrench in the works. Hopefully, by the 17th we will be back in business or else we my have to learn how to speak Chinese. After all they do own most of our country's debt and I would imagine they won't be too pleased when they don't receive their monthly interest payments on time.
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Post by babaoriley on Oct 7, 2013 10:09:50 GMT -5
If the current shutdown is all that is keeping them from filing, I don't care much; if it's something else, I care a lot; don't like price action recently.
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Post by babaoriley on Oct 7, 2013 10:12:05 GMT -5
By the way, Stevie (and many people think as you do), the Chinese aren't close to owning most of this country's debt.
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Post by StevieRay on Oct 7, 2013 10:24:07 GMT -5
Well they do own a lot of it according to this Wikipedia: en.wikipedia.org/wiki/National_debt_of_the_United_States" Foreign holdings[edit]
Composition of US Long-Term Treasury Debt held by foreign states, Nov. 2005–Nov. 2010. June figures are results of comprehensive Treasury Department surveys. As of January 2011, foreigners owned $4.45 trillion of U.S. debt, or approximately 47% of the debt held by the public of $9.49 trillion and 32% of the total debt of $14.1 trillion.[70] The largest holders were the central banks of China, Japan, Brazil, Taiwan, United Kingdom, Switzerland and Russia.[72] The share held by foreign governments has grown over time, rising from 13% of the public debt in 1988[73] to 25% in 2007.[74]
As of May 2011 the largest single holder of U.S. government debt was China, with 26 percent of all foreign-held U.S. Treasury securities (8% of total U.S. public debt).[75] China's holdings of government debt, as a percentage of all foreign-held government debt, have decreased a bit between 2010 and 2011, but are up significantly since 2000 (when China held just 6 percent of all foreign-held U.S. Treasury securities).[76] Major Foreign Holders of U.S. Treasury Securities, 2000–2010 Source: FutureofUSChinaTrade.com
Major foreign holders of U.S. Treasury securities, June 2010-May 2011[77] This exposure to potential financial or political risk should foreign banks stop buying Treasury securities or start selling them heavily was addressed in a June 2008 report issued by the Bank of International Settlements, which stated, "Foreign investors in U.S. dollar assets have seen big losses measured in dollars, and still bigger ones measured in their own currency. While unlikely, indeed highly improbable for public sector investors, a sudden rush for the exits cannot be ruled out completely."[78]
On May 20, 2007, Kuwait discontinued pegging its currency exclusively to the dollar, preferring to use the dollar in a basket of currencies.[79] Syria made a similar announcement on June 4, 2007.[80] In September 2009 China, India and Russia said they were interested in buying International Monetary Fund gold to diversify their dollar-denominated securities.[81] However, in July 2010 China's State Administration of Foreign Exchange "ruled out the option of dumping its vast holdings of US Treasury securities" and said gold "cannot become a main channel for investing our foreign exchange reserves" because the market for gold is too small and prices are too volatile.[82]
According to Paul Krugman, "It’s true that foreigners now hold large claims on the United States, including a fair amount of government debt. But every dollar’s worth of foreign claims on America is matched by 89 cents’ worth of U.S. claims on foreigners. And because foreigners tend to put their U.S. investments into safe, low-yield assets, America actually earns more from its assets abroad than it pays to foreign investors. If your image is of a nation that’s already deep in hock to the Chinese, you’ve been misinformed. Nor are we heading rapidly in that direction."[83]"
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Post by brentie on Oct 7, 2013 10:44:35 GMT -5
Prescription Drug User Fee Act (PDUFA) [10/1/2013] In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution ("lapse period"), agency operations will be limited to the following: Emergency work involving the safety of human life or the protection of property; Criminal law enforcement work; and Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period. www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htmEXCEPTIONS TO FEE REQUIREMENTS 14. Are there any exceptions to the fee requirements? Yes, there are exceptions. For Application Fees Previously Filed Applications or Supplements. If an application or supplement was submitted by a person that paid the fee for the application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver), The resubmission of the application or supplement for the same product (by the same person) does not require an application fee. www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069943.htm
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Post by StevieRay on Oct 7, 2013 11:12:22 GMT -5
I guess the thinking here is since we've already filed our NDA and paid the original filing fee that any subsequent submission is treated as a supplement and should be processed during the partial government shutdown. It sounds good to me but knowing the large bureaucratic process there is a chance that a small bottle neck channel may be closed which would hold up the processing. -We are not accepting NDA submissions be we are processing supplements but the input to the supplements comes from the closed channel, NDA submissions department which just happens to be located just across the hallway. And we are not authorized to walk over there and accept processing materials. They have to rubber stamp them for processing and we don't have access to their rubber stamp since the government is partially shutdown.
So I wouldn't get my hopes set to high but if it does happen on time I will be very pleased along with many other shareholders.
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Post by liane on Oct 7, 2013 11:18:59 GMT -5
I'm glad to see that the resubmission should not cost MNKD anything. I do hope that's true - saves the company on the order of $1.8M.
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Post by babaoriley on Oct 7, 2013 11:20:26 GMT -5
Stevie, thanks for posting the Wikipedia article. The Fed is by far the largest holder of our own debt. Of foreign holdings, China is tops. This share price action continues to concern me; difficult to believe it has been so weak just based on the shutdown. I sold some November $4 puts earlier today, should have waited a bit longer!
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Post by StevieRay on Oct 7, 2013 11:29:21 GMT -5
The share price is very depressing but I have great hopes for the future so I continue to hold tight to my conviction that Afrezza will be approved and eventually thrive in the marketplace. But it is very tough to watch.
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Post by vdhingra on Oct 7, 2013 12:16:03 GMT -5
anybody else chomping at these prices ...
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Post by mannmade on Oct 7, 2013 12:28:50 GMT -5
I just spoke with Roberta at mnkd. They will be filing the NDA on time and currently expect an FDA opinion on or before the previously announced date in April.
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Post by babaoriley on Oct 7, 2013 16:18:15 GMT -5
manmade, thanks for going the extra yard, makes me feel a bit better.
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Post by mannmade on Oct 7, 2013 16:37:04 GMT -5
Very welcome... I have learned a lot from you guys (and ladies). Feel like we are in it together...
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Post by mnkdfan on Oct 7, 2013 19:59:49 GMT -5
Thank you for the update Mannmade. Did Roberta give you a submission date.
It's been a bummer watching the share price drift downward. Not sure if the news about Novo committing large $$ to develop oral insulin spooked investors today but they are a long way away if at all from having an oral insulin solution. I bought a little more today.
Also, checked the company web site today and found they've added an additional 11 job listing for the Danbury site. Very encouraging- just hope the price reverse trend soon.
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