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Yep, I am betting alot of things very positive are going on behind the scenes which will reflect in the stock price soon enough and when this turns she's gonna move up strong I have a feeling..imo
I see $5+ coming short term here,again to the Naysayers,...DR. KENDALL isn't here for nothing !...watch..in my opinion
TGLO is spring loaded,the float is tight as hell, look how it moves on hardly any volume..this is ready to pop in a big way...imo
Wrong Pal !
I agree 100% !!
LOL..Cafe Pharma...are you serious..
FDA Determines that Afrezza REMS Communication Plan Has Met Goals and REMS No Longer Necessary
MannKind Corporation (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced that the Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk Evaluation and Mitigation Strategy (REMS) communication plan regarding the risks of Afrezza has been completed and has met its goals. As a result, the FDA has decided that a REMS is no longer required for Afrezza.
“We are pleased that the FDA determined that a communication plan is no longer necessary to ensure the benefits of Afrezza outweigh its risks and that a REMS is no longer required,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “We are grateful for the FDA’s guidance and expediency in this process, and we look forward to advancing our goal of establishing inhaled insulin as a preferred treatment option for individuals with diabetes who require mealtime glucose control.”
The FDA approved the original REMS for Afrezza in June 2014, and a REMS modification took effect in April 2015. The REMS consisted of a communication plan intended to inform prescribers of Afrezza of the potential risks associated with the use of Afrezza as described in the boxed warning. Two subsequent REMS assessments were conducted following Afrezza’s approval, and both assessments found that the communication plan met its goals.
The release of the REMS means that no further assessments are necessary; had it not been released, additional assessments would have been conducted at seven years post-approval. The Afrezza website, www.afrezzarems.com, will be inactivated, and the Company will no longer be required to distribute the Afrezza fact sheet at scientific meetings.
About Afrezza®
Available by prescription, Afrezza® (insulin human) inhalation powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.
About MannKind
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) inhalation powder, the Company's first FDA approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2017. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
MannKind Contact:
Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com
She's gonna blow to the upside in a Major way at any time,under $2 kiss goodbye imo
Stop smoking crack
Better cover shortie...imo
SWEET !!...Don't bet against Mike C. and Dr. Kendall !!!
Nope,under $2 is history soon imo
Its a good luck omen )
Getting ready for Big move to upside imo
You're wrong imo
Totally Disagree...
MNKD..eom
Strong volume today,under $2 is about to be history imo
MNKD..here we go...
MNKD ready
Any word on what's going on ?
tia
Good Stuff!!
Awesome !!, Thanks for the update,on the launch pad !
imo
Things change
I'm sure he knows he will make out fine..imo
Kresa in no dummy,he sees what MNKD will become. $6 will look like peanuts in my opinion in the not to distant future
imo
Blackout Period
Huge..Huge Upside remains !!
Imo
You hit the nail on the head !!
Won't happen..this is bottom
Imo
I'm sure if something did happen they are moving towards another deal..imo
Sweet !!...WMAC $$$$
WSCC.. eom
Boomage coming !!
Imo
WSCC $$
Hmmmmmmmmmmm $$$$$$