Mannkind, Game-Chancer in Sachen Diabetik? (Seite 237)

[checkpointuk]

...bin auch an Bord

Mal schauen, was heute aus dieser News gemacht wird - könnte spannend werden

[bernd1980]

mal abwarten, biss es bei den Amis öffnet, aber es sieht sehr gut aus!
Afrezza scheint nun endlich richtig anerkannt zu sein und die Akzeptanz dieser "Medizin" wird sich schlagartig steigern. Dauert nicht mehr lang und ein Großer wird an die Tür klopfen .

[pulloverschaf]

Antwort auf Beitrag Nr.: 57.621.288 von Magnetfeldfredy am 25.04.18 06:55:13

Sauber nun geht es los 👍💪🏻

[pegasusorion]

Antwort auf Beitrag Nr.: 57.621.327 von Magnetfeldfredy am 25.04.18 07:11:46

Würde auch das vorherige runterprügeln der Shortis erklären, dann ist der Gewinn in die Gegenrichtung höher oder?

[Magnetfeldfredy]

Therefore, because the communication plan is no longer necessary to ensure the benefits of the
drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation
powder.

https://charts.stocktwits.com/production/original_121113476.…

[Magnetfeldfredy]

Nachhaltig, langfristig ja, kurzfirstig werden die shorts wieder versuchen alles kleinzureden, jedoch haben Börsengurus folgende Meinung:

Wow @NatesNotes, any thoughts on this? I suspect we will get formal clarity this week. Cheers

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Nate's Notes
‏

@NatesNotes
Folgen @NatesNotes folgen
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Antwort an @sparkrov @drty_130
Heh - all I know is the efficacy of Afrezza has been the one constant through everything, and I continue to believe $MNKD is a strong buy under $5 and a buy all the way up to $10... cheers!

20:48 - 24. Apr. 2018 aus Healdsburg, CA

[pegasusorion]

Antwort auf Beitrag Nr.: 57.621.294 von Magnetfeldfredy am 25.04.18 06:58:04

Schaun wir mal ob das auch nachhaltig wird???

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 57.621.288 von Magnetfeldfredy am 25.04.18 06:55:13

Das kann der endgültige Durchbruch sein, bravo Dr. Kendall + Michael Castagna!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 57.621.117 von pulloverschaf am 25.04.18 05:52:10

Riesenschritt in Richtung bessere Vermarktung, bessere Versicherungsabdeckung, bessere Ärzteüberzeugung, Verpartnerung ........ die Kinderstudie ist viel einfacher.....

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
NDA 022472/S-017
SUPPLEMENT APPROVAL
MannKind Corporation
Attention: Robyn Walsh, M.S.
Senior Manager, Regulatory Affairs
One Casper Street
Danbury, CT 06810
Dear Ms. Walsh:
Please refer to your supplemental New Drug Application (sNDA) dated and received
April 19, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
(FDCA) for Afrezza (insulin human) inhalation powder.
This Prior Approval sNDA provides for proposed modifications to the approved Afrezza risk
evaluation and mitigation strategy (REMS). This supplement is in response to our
April 17, 2018, REMS Modification Notification letter.
We have completed our review of this supplemental application. It is approved effective on the
date of this letter.
RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
The REMS for Afrezza (insulin human) inhalation powder was originally approved on
June 27, 2014, and the most recent REMS modification was approved on April 20, 2015. The
REMS consists of a communication plan and a timetable for submission of assessments of the
REMS. In order to minimize burden on the healthcare delivery system of complying with the
REMS, we determined that you were required to make the REMS modifications outlined in our
REMS Modification Notification letter dated April 17, 2018.
Communication Plan: We have determined that the communication plan is no longer necessary
as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder
outweigh its risks because the communication plan has been completed and the most recent
assessment demonstrated that the communication plan has met its goals. No further assessments
are necessary to assess the current communication plan.
Therefore, because the communication plan is no longer necessary to ensure the benefits of the
drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation
powder.
Reference ID: 4252859
NDA 022472/S-017
Page 2
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients (which includes new salts and new fixed combinations), new indications, new
dosage forms, new dosing regimens, or new routes of administration are required to contain an
assessment of the safety and effectiveness of the product for the claimed indication in pediatric
patients unless this requirement is waived, deferred, or inapplicable.
Because none of these criteria apply to your supplemental application, you are exempt from this
requirement.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).
If you have any questions, call Michael G. White, Ph.D., Regulatory Project Manager, at
[phone].
Sincerely,
{See appended electronic signature page}
Jennifer Rodriguez Pippins, M.D., M.P.H.
Deputy Director for Safety
Division of Metabolism and Endocrinology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research

[pegasusorion]

Antwort auf Beitrag Nr.: 57.621.117 von pulloverschaf am 25.04.18 05:52:10

Deshalb hatte ich auch um 1,30€ ordentlich aufgestockt