Die verkaufen nicht den Hauch von Macrilen.....
|
|
Die Probleme der Kostenübernahme, seitens der Krankenversicherungen, sind doch langgenug bekannt. Mac ist ja auch nicht ganz billig. In der EU wird sich das ebenso wiederspiegeln. Ohne Orphan Status wird es bei den Erwachsenen schwierig.
Bei den Kinderchen könnte sich das ändern, nicht nur wegen dem Risikoprofiel, sondern auch durch die Unzuverlässigkeit der anderen Tests. Daher gibt es bei CGHD momentan keinen Goldstandard.
September 21, 2020
Controversies persist in diagnosing, treating GH deficiency, short stature in children
-------The diagnosis of GH deficiency in childhood — whether congenital or acquired, idiopathic or organic — remains challenging, in large part due to the lack of a true gold standard and the relatively poor performance of available diagnostic testing, according to experts---------
-----Pharmacologic agents used to stimulate GH production also vary across the U.S., Mauras said.
“There is a hodgepodge of secretagogues people use,” Mauras said. “Some use glucagon, some use L-arginine, L-dopa or clonidine. The tricky part is you may perform the same test on the same child 3 days in a row and get three different answers.”------------------
https://www.healio.com/news/endocrinology/...hort-stature-in-children
http://Growth hormone stimulation test with Clonidine and Arginine an unreported side effect
Ich sehe es nicht so, dass Novo unser Mac nicht verkaufen will. Es will oder kann sich nur keiner leisten. Beim Co-Pay-Programm ist auch noch die Frage wer überhaupt und welche Vergünstigungen bekommt. Bei den Verkaufszahlen kann das nicht die Masse sein.
Dabei geht es bei Mac doch nicht nur um GHD.
August 30, 2020.
Biochemistry, Ghrelin
-----------The many functions of ghrelin have stimulated interest in several potential clinical applications including obesity, anorexia, COPD, cancer cachexia, gastroparesis, growth hormone deficiency, alcohol addiction, and many others. However, to date, we do not have indubitable documentation of a syndrome of ghrelin excess or deficiency in humans
https://www.ncbi.nlm.nih.gov/books/NBK547692/
Denke den Mac-Wert an den jetzigen Verkaufszahlen festzulegen ist falsch. Die Biofirmen rechnen in Jahren und nicht nur in Monaten. Allein CGHD hat m.E. gute Chancen nach der Zulassung zu punkten. Das Problem der noch nicht erfolgten Lizenzdeals sehe ich eher an den noch ausstehenden Zulassungen. Sobald die eine gewisse Sicherheit erreicht habern wird sich auch was ergeben.
As of August 28, 2020, there were 62,678,613 Common Shares issued and outstanding
Cash runway to fund operations through 2023 / Based on Management’s current expectations and planned development activities
Warrants as at August 5, 2020
Warrants | Exercise Price | |||||||||
# | $ | Expiry date | ||||||||
December 2015 registered direct offering | 2,331,000 | 7.10 | December 13, 2020 | |||||||
September 2019 registered direct offering | 3,325,000 | 1.65 | September 24, 2024 | |||||||
February 2020 Financing | 2,608,696 | 1.20 | August 21, 2025 | |||||||
February 2020 Financing | 243,478 | 1.61719 | February 19, 2025 | |||||||
July 2020 Financing | 26,666,666 | 0.45 | July 7, 2025 | |||||||
July 2020 Financing | 1,866,667 | 0.5625 | July 1, 2025 | |||||||
August 2020 Financing | 9,320,907 | 0.47 | February 5, 2026 | |||||||
August 2020 Financing | 869,952 | 0.7040625 | August 3, 2025 | |||||||
47,232,366 |
Termine 2020:
Q1 ---- Ende PIP 01 (Kindrstudie)
10. März --- Ende der Serie A Warrants
24. März ----- Die 1,65$ September 2019 Warrants dürfen ausgeübt werden
1 April -------Beneficial Ownership Determination Date/ Record Date for Voting
6.April ------- Finale Ergebnisse PIP 01 (positive Results In Dose-finding)
1. Mai ------- Ende der 945T 4,7$ Warrants
15. Mai ------- Annual Meeting
8 Juni -------- Registrierung der 2019 und 2020 Warrants (Verkauf über den Markt zulässig)
25 Juni -------- Megapharm Distribution Agreement
7 Juli ----------- CLOSING OF $12 MILLION PUBLIC OFFERING
5.August -------- CLOSING OF $7 MILLION PUBLIC OFFERING
28.August ---------- Zulassung Novo Somapacitan adult US
13. Dez ---------- Ende der 2,33 Mio 7,1$ Warrants
ca. Jan 2021--------- mögliche Zulassung Novo adult EU
25. Jan 2021 ----------- NASDAQ 1$ Regel (Ende erste 180 Tage)
Q1. 2021 -------- geplant Anfang PIP 02
25.6.21 ----------- mögliche Zulassung Ascendis Pharma pediatric US
Ende Juli 2021 ----------- NASDAQ 1$ Regel (Ende zweite 180 Tage) mögliches Delisting
Q3 2021 -------------- mögliche Zulassung Ascendis Pharma pediatric EU
Q3 - Q4 ------------- mögliche Zulassung Opko Pfizer pediatric US / EU
Q2 2022------- geplant Ende PIP 02
min H1 2023 ------------- AEterna mögliche EMA/FDA Zulassung pediatric US / EU
Zulassungen
28.8.2019 Novo submission BLA adult FDA
ca August 2019 Novo sumbission MAA für EU
26.6 2020 Ascendis Pharma submission BLA pediatric FDA
28.8.2020 Novo Zulassung adult US
8.9 2020 Ascendis Pharma submission MAA pediatric EMA
bald Opko/Pfizer submission BLA pediatic https://www.fiercebiotech.com/biotech/...ormone-data-ahead-fda-filing
ca. 1.2020 mögliche Zulassung Novo adult EU
25.6.2021 PDUFA Ascendis Pharma pediatric US
ca Q3 2021 mögliche Zulassung Ascendis Pharma pediatric EU
7. Commercialization.
7.1 Licensee shall either itself or through its Affiliates, and Sub-licensees Commercialize the Product in the Territory using Commercially Reasonable Efforts and 'Commercially Reasonable Efforts' for these purposes shall include, but not be limited to the Licensee:
(a) ;
and
(b) ensuring, that notwithstanding the resources required by the Licensee for the preparation for and the launch of another product by the Licensee (or its Affiliates), it continues to provide an appropriate level of resources dedicated to the Commercialization of the Product.
14. Duration and termination of the agreement
14.1 The Agreement shall enter into force and effect on the Effective Date and shall remain in full force and effect country by country of the Territory for the duration of the Term, subject to earlier termination as provided in this Agreement. At the expiry of the Royalty Term in each country of the Territory the licenses granted by the Parties hereunder shall become perpetual, irrevocable, fully paid up and royalty free in such country.
14.2 The Licensee shall be entitled to terminate the Agreement:
(a) effective immediately upon prior written notice to the Licensor pursuant to Section 7.11(d), if the Licensee can demonstrate that there are reasonable good faith grounds to believe there is a safety concern related to the Product, or
https://app.quotemedia.com/data/...ateFiled=2018-01-19&CK=1113423
Gab nach dem sbbp Deal ein internes Dokument, welches im ami Forum gepostet wurde in welchem AEZ dazu Stellung bezieht und die Ansicht vertritt, dass die pedi Lizenz durch den Deal nicht vergeben wurde, da es diese zum Zeitpunkt des Deals noch nicht gab bzw gibt.
Strongbridge hatte damals schon alle Rechte an Mac!
---------B. The Licensor is interested in assigning the ownership of the Product Registrations (as defined below) and granting an exclusive license under the intellectual property to the Licensee to carry out development, manufacturing, registration and commercialization of the Product in the Territory (as defined below).
--------- “Product” meansany pharmaceutical product containing the API, including the product developed by the Licensor for the Existing Indications and approved by the FDA for marketing in the United States under the NDA.
“API” means the active pharmaceutical ingredient macimorelin acetate, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.
Cash and cash equivalents 21,746
https://www.sedar.com/...nyDocuments.do?lang=EN&issuerNo=00003989
|
Wertung | Antworten | Thema | Verfasser | letzter Verfasser | letzter Beitrag | |
25 | 17.117 | Aeterna nach dem Split | Heron | Hbit | 25.11.23 10:08 | |
9 | 13.769 | AEZS vs. KERX | Gropius | paioneer | 03.09.22 18:22 | |
19 | Wie geht's jetzt weiter mit Aeterna Zentaris? | Ebi52 | Bullish_Hope | 03.08.22 00:11 | ||
21 | 7.680 | Aeterna Zentaris Inc. | Heron | Heron | 30.09.21 23:37 | |
2 | 62 | AEterna Zentaris (AEZS)- Reboundkandidat?? | Vollzeittrader | marroni | 25.04.21 13:13 |