MANNKIND - 2013 endlich zum Überflieger?
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Bridged safety data between medtone and dreamboat as requested by fda
safe and effective
met secondary endpoint
na dann hoffen wir mal auf ein positives Voting nächste Woche
Bitte lest euch in den US Special-Boards für Pharmaindustrie ein:
http://mannkind.freeforums.net/thread/498/adcom-docs-posted
http://mnkd.proboards.com/thread/568/briefing-docs?page=7
Für Diabetes 2 sichere Zulassung für Diabetes 1 eher mit Einschränkung.
Ich schätze die Aktie wird heute schon hochschießen und nach positivem Adcom am Mittwoch durchaus auf 15-18 $.
Am 15.4. wenn FDA die Freigabe macht gibt es keine Mannkind mehr unter 20$ schätze ich.
Alles Angstmacherei von den großen online Newspaper, das sogar einige positiv gestimmte wie Nates Notes hat seine positive Haltung von gestern auf der Internetseite gesperrt ( https://www.notwallstreet.com/about-nates-notes/ ). Seeking Alpha Jeff Eisemann fasst zusammen und sagt Afrezza wird freigegeben: http://seekingalpha.com/article/...ezza-implications-for-fda-approval
Bin heute auf den Handelstag gespannt die haben nur 6,5 h und die großen wollen sich noch einkaufen!
Morgen wird die Aktie ausgesetzt wegen der Adcom Sitzung.
Am Mittwoch sollte Mannkind spätestens einen Shortsqueeze bekommen mit 63 Mil. Shorts.
Viel Glück allen investierten!
https://www.notwallstreet.com/...ptimistic-ahead-adcom-meeting-32914/
Viel Glück allen Investierten!
von der Panelsitzung morgen über Stunden zu schalten...ich hoffe so, dass er mal wieder auf die Schnauze fliegt, dieser besserwisserische Schreiberling...
I am so proud and hate the fucking bahsers.......
13:1, 14:0, mehr sog I ned!
Wia geilllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll!
und die werden brennen die nächsten Wochen...bei 10$ ...dann bei bei 20$ und dann bei
Verpartnerung bei XX$...!!!
Wenn die Shorties sich in den letzten 2 Tagen nicht ausreichend eindecken konnten als der Kurs von knapp 6$ auf 4$ runterging und die Short Werte noch bei ca. 63 Mio liegt, gibt es hier ein noch nie gesehenes Feuerwerk!
Viel Glück an Alle investierten!
https://www.youtube.com/watch?v=ylin1ZSDo0o
Na ja, die Applikation von Insulin über die Lunge sehe ich auch nicht als die Zukunft der Therapie.
Da gibt es interessantere Ansätze, z.B. die orale Gabe. Tabletten sind für Patienten immer die am Einfachsten zu handhabende Möglichkeit.
Wen es interessiert, Oramed ist aktiv, neben Novo Nordisk, die spielen natürlich auch mit.
Das ist das einzige ultra schnell wirkende Insulin weltweit und kann diskret überall mit dem winzigen pfeiffengroßen Inhalator ohne Kühlung eingenommen werden!
Gamechanger in Sachen Diabetik, darum das FDA Adcom von 13:1 und 14:0 zugunsten Afrezza!
MannKind Corporation Earnings: Are Better Times Ahead?
By Dan Caplinger | More Articles | Save For Later
May 10, 2014 | Comments (0)
On Monday, MannKind (NASDAQ: MNKD ) will release its quarterly report, and investors don't expect any immediate positive results from the clinical-stage biotechnology company. The company has been waiting for a long time for FDA approval of its Afrezza inhaled insulin product, but established insulin producers Eli Lilly (NYSE: LLY ) and Novo Nordisk (NYSE: NVO ) are working hard to protect their competitive advantage, and it's still unclear whether MannKind will convince the FDA that any safety issues with Afrezza are less substantial than the potential benefits.
Dealing with insulin is a big hassle for patients suffering with diabetes, as the need for injections is at best a chore and at worst can cause complications for diabetics. The promise of an inhalable insulin product is attractive to many diabetes sufferers, and that has driven interest in MannKind for years. Yet investors are impatient for FDA approval to see just how big the opportunity will be for MannKind, especially in light of potential competition. Let's take an early look at what's been happening with MannKind over the past quarter and what we're likely to see in its report.
Dreamboat (2nd generation) inhaler. Source: MannKind.
Stats on MannKind
Analyst EPS Estimate
($0.13)
Year-Ago EPS
($0.15)
Revenue Estimate
$0
Year-Ago Revenue
$0
Earnings Beats in Past 4 Quarters
0
Source: Yahoo! Finance.
Will MannKind earnings ever appear?
With MannKind earning no revenue, analyst earnings projections all hinge on how much they expect the company to spend. Those loss projections have risen recently, with first-quarter loss estimates widening 30% and full-year 2014 loss projections widening by 40%. Yet the stock is up 22% since early February.
MannKind's fourth-quarter financial report didn't hold any big surprises for investors. Operating expenses rose 39%, with the rise coming largely from stock-based compensation charges. Losses per share fell, but only because the number of shares MannKind had outstanding rose dramatically.
The key event for MannKind during the quarter, though, came in April, when an FDA advisory committee recommended that Afrezza be approved, with a unanimous 14-0 vote for type 2 diabetes and by 13-1 for type 1 diabetes. That news was especially welcome because of a scare among investors when the advisory panel presented its briefing materials, which indicated that MannKind had thrown some curveballs at the FDA.
Unfortunately, MannKind investors haven't gotten everything they wanted, as the FDA announced that it would delay its full approval decision beyond its initial April 15 deadline. Yet even though some investors got nervous about the delay, the fact that the deadline fell so close to the date on which the advisory panel made its recommendation is a good reason for the FDA to give itself more time to evaluate briefing materials and make a more considered decision.
One essential aspect of MannKind's future is whether it will find a partner for distributing Afrezza if it gains FDA approval. Because Eli Lilly and Novo Nordisk compete directly against Afrezza with insulin products of their own, MannKind will likely have to look elsewhere for potential partners. Yet with some other major pharmaceutical companies looking to ramp up their exposure to the diabetes space, MannKind should find little trouble gaining interest -- as long as the product gets approved.
In the MannKind earnings report, investors will want to listen for whether the company has made progress in finding a partner. For the most part, though, investors simply have to wait and see what the FDA has to say before MannKind can come up with a strategy for making the most of the Afrezza opportunity.
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Dan Caplinger and The Motley Fool have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
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Dan Caplinger
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Dan Caplinger has been a contract writer for the Motley Fool since 2006. As the Fool's Director of Investment Planning, Dan oversees much of the personal-finance and investment-planning content published daily on Fool.com. With a background as an estate-planning attorney and independent financial consultant, Dan's articles are based on more than 20 years of experience from all angles of the financial world.
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Related Tickers
5/9/2014 4:02 PM
LLY $59.36 Down -0.14 -0.24%
Eli Lilly & Co. CAPS Rating: ****
MNKD $6.22 Up +0.06 +0.97%
MannKind Corp CAPS Rating: **
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