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"allow Respondent to temporarily commercially continue operating"...
http://www.sec.gov/Archives/edgar/data/1381105/000121390010005243/f8k121510ex99ii_jbi.htm
commercial production has been allowed "temporarily"....
that's why this statement is misleading:
"Commercial Production has been approved by the NY DEC."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60457628
could not find the "milestone dates" in "Schedule A".... is "Schedule A" hiding?
"Stipulated Penalty. In the event Respondent fails to satisfy the milestone dates imposed in Schedule A"
PERIOD OF NON-COMPLIANCE
PENALTY PER DAY
1st Day through 30th Day $ 500
31st Day through 40th Day $750
41st Day through 50th Day $1,000
51st Day through 60th Day $1,500
Each Day beyond the 60th Day $2,500
"commercial production" while "pending"...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60472058
its not "pending" anymore... decision is "Suspended Indefinitely"...
http://www.dec.ny.gov/cfmx/extapps/envapps/index.cfm?view=detail&applid=759800
"NEW air permit application".....? link?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60473069
yes it is misleading....
"The NY DEC approved commercial production pending issuance of requisite environmental permits."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60472058
"pending issuance".... is "Suspended Indefinitely"...
http://www.dec.ny.gov/cfmx/extapps/envapps/index.cfm?view=detail&applid=759800
this post is completely misleading...
"suspended" means "approved"?...
JBII DEC Permit - Status - Suspended Indefinitely as of 12/14/2010
http://www.dec.ny.gov/cfmx/extapps/envapps/index.cfm?view=detail&applid=759800
NLTX - Nile Therapeutics to Collaborate with Medtronic on Clinical Development of Cenderitide for Heart Failure and Renal Disease
PRESS RELEASE
February 28, 2011
Nile Therapeutics to Collaborate with Medtronic on Clinical Development of Cenderitide for Heart Failure and Renal Disease
SAN MATEO, CA, February 28, 2010 -- Nile Therapeutics, Inc. (NASDAQ: NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced plans to collaborate with Medtronic, Inc. (NYSE:MDT) on the clinical development of Nile's proprietary natriuretic peptide, cenderitide (formerly CD-NP), for heart failure and renal disease applications.
"We are very pleased to partner with Medtronic on cenderitide," said Joshua Kazam, Chief Executive Officer of Nile Therapeutics. "This collaboration will be an important step on our path to developing cenderitide as a potential new therapy for patients with cardiovascular and renal disease following hospitalization for acute heart failure."
Under the terms of the agreement, Medtronic will fund and provide its drug-device expertise as Nile executes on its Phase I clinical trial to assess the pharmacokinetics and phamacodynamics of cenderitide delivered through Medtronic diabetes pump technology. In the planned clinical trial, cenderitide will be delivered to heart failure patients for up to 24 hours through continuous subcutaneous infusion. Nile expects to complete the trial by the first quarter of 2012. Financial terms were not disclosed.
Following the Phase I study, Nile intends to initiate a larger Phase II double-blind, placebo-controlled, dose ranging study in patients admitted to the hospital for acute heart failure. The planned Phase II study will evaluate the endpoints of cardiac remodeling, renal function, re-hospitalization and mortality in patients following 90 days of continuous therapy via subcutaneous pump. The first 90 days following admission to the hospital is a critical time for heart failure patients who are known to have combined rates of re-admission and mortality as high as 50% during that period. Nile believes that the cardiac unloading and renal preserving properties of cenderitide could have a significant benefit to patients during a critical time in their recovery from acute heart failure.
About Heart Failure
Heart failure is the fastest-growing clinical cardiac disease in the U.S. according to the American Heart Association, affecting over 5 million Americans. Over 1 million patients in the U.S. each year are hospitalized with ADHF, an acute exacerbation of heart failure. This hospitalization rate is almost double the rate seen 15 years ago, and is the most frequent cause of hospital admission in the U.S. for patients older than 65 years, generating annual inpatient costs of more than $33 billion.
About Nile Therapeutics
Nile Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is initially focusing its efforts on developing its lead compound, CD-NP, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure, and CU-NP, a novel rationally designed natriuretic peptide. More information on Nile can be found at http://www.nilethera.com.
Contact:
Daron Evans
Chief Financial Officer
Nile Therapeutics, Inc.
+1-650-458-2670
info@nilethera.com
Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Nile's plans to develop cenderitide in the post-acute setting, the anticipated benefits of cenderitide for patients in the post-acute setting, and Nile's plans to initiate clinical trials in the post-acute setting, are forward-looking statements. Forward-looking statements also include statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial timelines, expected patient enrollment, anticipated benefits of cenderitide, Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile's need to raise additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission on March 3, 2010. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
NLTX - Nile Therapeutics Announces Plans to Pursue a Post-Acute Indication in Heart Failure
PRESS RELEASE
February 28, 2011
Nile Therapeutics Announces Plans to Pursue a Post-Acute Indication in Heart Failure
SAN MATEO, CA, February 28, 2011 – Nile Therapeutics, Inc. (NASDAQ: NLTX), a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, announced plans to pursue a new indication in the field of heart failure. Nile plans to develop cenderitide (formerly CD-NP) as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital. This is a novel therapeutic space for natriuretic peptides that has been termed "post-acute."
Within 90 days of admission for ADHF, approximately 40% of patients return to the hospital. Post-acute patients need sustained cardiac and renal function support to prevent a recurrence of their acute symptoms. In multiple clinical trials in both acute and chronic heart failure patients, short-term infusion of cenderitide has been shown to have positive effects on cardiovascular and renal parameters. Nile believes that the continuous and extended infusion of cenderitide through a subcutaneous pump will provide patients with sustained symptomatic relief in the outpatient setting that could contribute to a reduction in post-acute hospitalizations and persistent improvement in cardiorenal functions.
"With over 1 million admissions per year in the U.S., at a cost of over $33 billion, ADHF is one of our country's most expensive health problems," said Richard B. Brewer, Nile's Executive Chairman. "We believe that cenderitide has an opportunity to address a true unmet need in heart failure, and could help reduce the overall cost of health care."
Nile recently had a productive meeting with the United States Food and Drug Administration (FDA) on the development of cenderitide as an extended subcutaneous therapy for a post-acute indication. Nile will seek a FDA Fast-Track Approval Designation for this post-acute indication. Before the end of the second quarter of 2011, Nile plans to file a new Investigational New Drug (IND) application and to initiate a Phase I pharmacokinetics and pharmacodynamics (PK/PD) clinical trial. Following the PK/PD trial, Nile intends to initiate a Phase II double-blind, placebo-controlled, dose-ranging clinical trial in post-acute heart failure patients in the first half of 2012.
"This new path represents the identification of an opportunity that incorporates the current clinical, scientific, and regulatory perspectives on the development of heart failure therapeutics," said James Young, MD, Professor and Executive Dean, Cleveland Clinic Lerner College of Medicine. "Preclinical and clinical data have shown that the natriuretic peptide class can act on multiple disease processes that play a role in the negative outcomes associated with heart failure. The unique properties of cenderitide provide a sound rationale to support this innovative strategy and could lead to the development of a differentiated product with clinically meaningful benefits."
About Nile Therapeutics
Nile Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is initially focusing its efforts on developing its lead compound, cenderitide, a novel, rationally designed chimeric peptide for the treatment of heart failure, and CU-NP, a second novel, rationally designed natriuretic peptide.
More information on Nile can be found at http://www.nilethera.com.
Contact:
Daron Evans
Chief Financial Officer
Nile Therapeutics, Inc.
+1-650-458-2670
info@nilethera.com
Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Nile's plans to develop cenderitide in the post-acute setting, the anticipated benefits of cenderitide for patients in the post-acute setting, and Nile's plans to seek Fast Track designation of Cenderitide and initiate clinical trials in the post-acute setting, are forward-looking statements. Forward-looking statements also include statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial timelines, expected patient enrollment, anticipated benefits of cenderitide, Nile's strategy, future operations, outlook, milestones, the timing and success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile's need to raise additional capital to fund its product development programs to completion, Nile's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption "Risk Factors" in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission on March 3, 2010. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
LNGT posts from last week when pps was in the low 5s... enjoy!
funny stuff.... dude
solid buys at 5.5 cents keep coming in..... dude
they've shown interest.... no big deals have taken place in this market.... not yet...
dude
not really... without demand in the dazzler market none of that matters...
but yes,. the DL is superior amongst its competitors... when the demands hits the market it should be an easy choice... must wait for that to happen...
dude
Don't Hate The Playa, Hate The Game
its going to take time for that big contract... BB has no control over the market...
this brand new market is our only enemy here... its clear there are no big buyers in the market... its still politics at this point...
but, rest assured that,.. if our competitor lands that big order before us... you won't be the only one blaming this company...
until then... don't hate the playa, hate the game...
dude
the conclusion that LEI cannot progress because it cannot finance GD is erroneous at best... protesting about it is ridiculous...
why not bash about LEI not landing large contracts??? at least thats logical...
dude
solid easy bounce from the 4s! dude
HELLO 6s... LNGT ON THE MOVE!!!!
dude
Exactly… LNGT does not need the “millions” to pay GD… that’s because the DLs are not being manufactured by GD at this point!!! Why is there confusion about this???
Unless LNGT scores big volume the DL will never be manufactured by GD!!!
dude
LNGT is extremely thin. a little buying pressure and take-off!
dude
nice finish today! wow!
dude
LNGT ON THE MOVE!
nice day so far!
dude
please provide evidence to support this new type of bashing.
thanks. dude
LNGT REPORT
1. small swinger sell-off into the 4 cent region over the past two weeks.
2. bullish investors buy at all ranges recovering the price into the 5 cent mid region.
3. extremely thin trading. shares held tightly. easy bounce!
dude
LNGT - recovered from swinger sell-off!
you keep up the good work.... keep watching LNGT like a "hawk"...lol
your confused.... i don't care about the price... i care about the positive movement!!!
it doesn't matter when you got in... whether you are at a loss or gain...if you and/or your friends got money in this... you should be happy when the price increases... irregardless of anything else...
its that simple... i suppose you'd rather watch the price decrease?
shouldn't you be happy about the pps gaining momentum!?
dude
another good day for LNGT. keep up the good work!
dudue
we went down because LNGT swing traders began to sell their shares very cheaply to others (including myself)... now shares are gone... we are back to where it started.... dude
LNGT NEWS COMING SOON?
(maybe after we hit 8s)... lol
dude
i disagree... lets wait and see... dude
all i'm saying is that its naive to wait for a delivery confirmation in the form of a PR... irrespective of the number delivered... be it 5 or 5M units... the information will hit the market from the buyers side...
naive LNGT investors will be caught in the loop waiting for the PR....dude
no problem... with LNGT, the news will trail the price from now on...
think about it, the purchasing organizations are under no obligation not to share information upon delivery... for example, take the police department...they are completely open about everything thats going on... information will reach the market before the PR is out...
dude
if he keeps up the good work will be back in the 8s in no time... dude
its thin... traded down from 30% on 3.7k shares...
it was really funny, thats all...
you don't have to defend him every single time...
dude