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Mithra in 2018 - Erop of eronder

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  1. [verwijderd] 19 juli 2018 11:38
    De communicerende vaten.

    Blijkt dat La Esterella s morgens nogal dikwijls met het verkeerde been uit bed stapt.

    Maar des avonds voor het slapengaan op tijd haar beste vorm weer vindt.

  2. [verwijderd] 19 juli 2018 12:05
    quote:

    Mopperaar schreef op 19 juli 2018 11:38:

    De communicerende vaten.

    Blijkt dat La Esterella s morgens nogal dikwijls met het verkeerde been uit bed stapt.

    Maar des avonds voor het slapengaan op tijd haar beste vorm weer vindt.

    haha, maar vanavond zie ik ze in de min eindigen, teveel in te halen

    we'll see
  3. JR von P 20 juli 2018 07:35
    MITHRA OBTAINS FIRST MARKETING AUTHORIZATION FOR MYRING™ IN EUROPE
    ? Marketing authorization allows for launch of Myring™ in the United Kingdom
    ? Additional marketing authorizations expected in the near future
    ? Mithra to produce Myring™ at its CDMO2
    Liège, Belgium, 20 July 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s
    Health, today announces that the company obtained its first marketing authorization (MA) for
    Myring™
    1
    in the UK, following approval by the MHRA2
    . Myring™ is Mithra’s contraceptive vaginal ring
    made of ethylene vinyl acetate copolymers (EVA) and is developed to be fully bioequivalent to Merck’s
    Nuvaring®. In April 2018, Nuvaring® went off patent in both the US and Europe. In the UK, which is a
    market worth approximately EUR 1.2 million3
    , no generic competition exists as of yet.
    Under the same decentralized procedure, in coming months, additional MA’s should be received for
    Croatia, Hungary, the Czech Republic, Poland, Latvia, Slovakia, and Slovenia, with further MA’s
    expected in Europe as well as the US later this year and early 2019.
    François Fornieri, CEO Mithra Women’s Health: “We are very pleased to obtain the first marketing
    authorization for Myring™. This is a great achievement for our team, highlighting our expertise in
    polymer technology and the manufacturing capabilities at our state-of-the-art CDMO facility. We are
    confident to receive MA’s in additional territories, including for the key US market, later this year or
    early 2019, and look forward to producing Myring™ for our partners at our CDMO.”
    *******
    About Myring™
    Myring™ is developed to be a generic of Nuvaring® vaginal ring. Nuvaring®’s patent expired in April
    2018 both in the US and in EU. Myring™ (etonogestrel/ethinyl estradiol vaginal ring) is a nonbiodegradable,
    flexible, transparent, combination contraceptive vaginal ring, with an outer diameter
    of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers, and
    contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring
    releases, in line with the originator (Nuvaring®), on average 0.120 mg/day of etonogestrel and
    0.015 mg/day of ethinyl estradiol over a three-week period of use. The ring is to remain in place
    continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed
    usually occurs. A new ring is inserted one week after the last ring was removed.

    1 Myring™ will be marketed under a different brand name in the UK.
    2 Medicines and Healthcare products Regulatory Agency
    3 CAGR (2013-2017): +6.6%
    PRESS RELEASE
    investors.mithra.com - 2
    For more information, please contact:
    Investor Relations
    Sofie Van Gijsel
    IRO & VP of Strategy
    +32 485 19 14 15
    investorrelations@mithra.com
    About Mithra
    Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women's health, with a
    particular focus on fertility, contraception and menopause. Mithra's goal is to develop new and
    improved products that meet women's needs for better safety and convenience. Its two lead
    development candidates - a fifth generation oral contraceptive, Estelle®, and a next generation
    hormone therapy, Donesta®- are built on Mithra's unique natural estrogen platform, E4 (Estetrol).
    Mithra also develops, manufactures and markets complex therapeutics and offers partners a
    complete spectrum of research, development and specialist manufacturing at its Mithra CDMO.
    Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof.
    Dr. Jean-Michel Foidart and is headquartered in Liège, Belgium. Further information can be found at:
    www.mithra.com
  4. [verwijderd] 20 juli 2018 07:49
    Is een peanutsachievement maar peanuts feeds an elephant.

    Beleggers zitten nu op grote deal te ge wachten voor verdeling van estelle/donests. Denk dat mithra beleggers gisteren gefrustreerd waren omdat galapagos wel iets gelijksaardig deed.

    Hopelijk een groen tapijtje vandaag na de rode menestruatieflauwte van gisteren.
  5. [verwijderd] 20 juli 2018 13:42
    quote:

    FilipVanderAa schreef op 20 juli 2018 11:34:

    Ik hoop en denk dat ze bedoelen 1,2 miljard euro :)
    nee hoor, 1,2 million ; t' is nog niet het pilletje he :-)
  6. forum rang 6 de tuinman 20 juli 2018 15:18
    quote:

    Elvisfan schreef op 20 juli 2018 13:42:

    [...]

    nee hoor, 1,2 million ; t' is nog niet het pilletje he :-)
    Maar dat is alleen UK, toch?
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