Mannkind, Game-Chancer in Sachen Diabetik? (Seite 21)

[Muckimann66]

15.10.2021 endet TRx 734 vs. 748 TRx Dollar 1,40 mm vs. 1,45 mm NRx 277 vs 297 NRx Dollar 573,54k vs 581,51k Refills 457 vs 451

[pegasusorion]

Antwort auf Beitrag Nr.: 69.638.184 von Magnetfeldfredy am 19.10.21 15:22:15

Sach ich doch 😎🤠

[price-of-success]

dann dauert es eben noch ein paar Monate

[Magnetfeldfredy]

Mannkind

Why Shares of MannKind Corporation Are Falling This Morning
Investors are hyperventilating after a delay for its inhaled medicine.
Jason Hawthorne
(TMFbonefish)
Oct 18, 2021 at 12:37PM
Author Bio
Follow @jhhawthorne
What happened

Shares of MannKind (NASDAQ:MNKD), a company working to develop inhaled therapeutics, were down 18% as of 11:59 a.m. EDT on Monday after an inspection issue derailed its hopes of approval for Tyvaso DPI, a lung disease therapy it developed with United Therapeutics (NASDAQ:UTHR).
An inspector at a production facility takes notes.

Image source: Getty Images.
So what

Tyvaso DPI is a potential treatment for pulmonary arterial hypertension (PAH), a condition where high blood pressure constricts or blocks blood vessels in the lungs. It's a rare disease with an occurrence rate that Johnson & Johnson estimates between 50 and 100 people per million. According to United Therapeutics' Securities and Exchange Commission filings, it owns two patents for treating PAH through inhalation that expire in 2024. That makes the delay especially impactful.

Despite the drop in shares, it isn't all bad news. The Food and Drug Administration's complete response letter didn't cite issues with MannKind's operations or even the clinical data submitted by the two companies. Instead, it was the inspection at a third-party facility that proved to be the fly in the ointment.
Now what

Prior to today's fall, MannKind stock had been up 12% in October. The stock now trades at levels from mid-August -- not that long ago. Perhaps that's because there is still a clear path to approval.

Management has expressed confidence that the issue raised by the FDA can be resolved quickly. The partners say approval of the drug candidate should still come by next summer. To that end, MannKind CEO Michael Castagna said it is stockpiling inventory in anticipation of the eventual green light.

For investors with a long-term horizon, today's drop should be seen as a temporary setback; the effectiveness of the treatment is not in question. That said, time is money. Waiting until next summer for approval is clearly something many shareholders were not anticipating.

[Magnetfeldfredy]

Mannkind

...und dafür hat UTHR 105 Millionen US Dollar bezahlt, dass es eine beschleunigte Bearbeitung gibt....., die FDA verarscht Alle und besonders gerne Mannkind!

Na ja, das angegebene Problem müsste aus dem Weg zu räumen sein, schlimmer wären Sicherheitsbedenken, neue Studien.... Gott sei Dank nicht!

[pegasusorion]

Wie ich schon geschrieben hatte

https://s1.q4cdn.com/284080987/files/doc_downloads/2021/10/2…

bitte selber übersetzen,

alles wird gut.!

😎🤠

[huetchen6]

schau eben mal rein, na was war den das gestern, fast einen Euro runter.

[fohlenpelzig]

Antwort auf Beitrag Nr.: 69.626.070 von pegasusorion am 18.10.21 13:14:56

Ich sehs wie Du und hab auch nachgelegt. Mal schauen, obs heute noch dreht…….

[huetchen6]

na,Einsammlung über Stop-Loos

[pegasusorion]

Also wenn ich das richtig übersetze, gibt es nur bei der Fertigungskontrolle des Präparates ein Problem mit dem Qualitätscheck im analytischen Test. Natürlich dürfen nur einwandfreie Medikamente ausgeliefert werden, das ist kein Beinbruch sondern eine Lappalie.

Ich hab zugekauft, der Kurs wird wohl noch nach oben drehen wenn die Profis begriffen haben um was es hier eigentlich geht? 😎🤠