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BioPharma« Terug naar discussie overzicht

PSDV

17 Posts
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  1. [verwijderd] 23 november 2009 22:16
    Dan mag je mij wel eens vertellen welke goedkeuring er gaat komen. Zit er ook in rond de 2,5 gemiddeld en weet alleen dat er resultaten van een fase 3(illuvien) aankomen in december. Hierop zouden ze als het goedgekeurd wordt en verkocht 20 % royalties krijgen. Kan wel een biljoenendrug worden(enige in zijn soort) maar kleine biotechjes zijn en blijven erg gevaarlijk, zeker als er zo'n laag volume is.
  2. [verwijderd] 14 december 2009 21:58
    Komt weer flink beweging in:

    NEW YORK (Dow Jones)--Shares of PSivida Corp. (PSDV) jumped as much as 15% Monday as investors eagerly awaited data from a Phase III trial of Iluvien.

    The company has said in the past that it expects to report safety and efficacy data from the trial by the end of December for the drug treating diabetic macular edema, a potentially blinding eye disease affecting over 1 million people in the U.S. There currently are no drugs approved by the Food and Drug Administration for DME, the company said.

    PSivida spokeswoman Beverly Jedynak said Monday the company hasn't released data yet, but that it has said it expects to by the end of the year.

    "People trade on expectations, and I think people are expecting something [to be released soon]," she said.

    In recent trading, shares jumped 13% to $4 on more than double the normal daily volume. They earlier traded as high as $4.09. Shares have more than quadrupled year-to-date, trading sharply higher than their 52-week low of 60 cents from March.

    In September, the company reported positive 18-month interim results from the study. And it said last month during its fiscal first-quarter results that if the data are positive, its partner Alimera Sciences Inc. will file a new drug application with the FDA in the second quarter of calendar 2010 and request priority view.

    Ladenburg Thalmann analyst Juan Sanchez said in a note last week that he continues to expect positive results for the data.

    He said there is "ample evidence intravitreal steroids are effective in the treatment of DME," and he believes both doses of Iluvien maintain sufficient steroid levels in the back of the eye. Iluvien is inserted into the eye in this course of treatment.

    "In essence, we believe Iluvien is the safest way to conveniently and continuously deliver steroid to the back of the eye compared to current treatment and view both dose groups favorably," Sanchez noted last month.

    He added he believes it will become the treatment of choice for DME, with off-label usage for other indications. Sanchez said the drug has the potential to become a $250 million to $450 million product in the U.S. and a $450 million to $600 million product worldwide, before considering off-label uses and potential approvals for other indications.

    -By Shara Tibken, Dow Jones Newswires; 212-416-2189; shara.tibken@dowjones.com;

    (END) Dow Jones Newswires

    December 14, 2009 13:35 ET (18:35 GMT)

    Zit er nog iemand van jullie in?
  3. dimmer 14 december 2009 22:59
    quote:

    Eisbear schreef:

    Zit er nog iemand van jullie in?
    Me, kleine positie op 3.28 en 3,75, lijkt wel een beetje op BDSI paar jaar terug. Loopt ie te ver op voor de resultaten stap ik vroegtijdig uit.
    Ik had een tijdje terug al een aardig ritje gemaakt van 2,3 naar 3 (veel te snel uitgestapt)
    succes!
  4. [verwijderd] 23 december 2009 15:09
    quote:

    spvthijs schreef:

    he he ik ga t jaar mooi afsluiten! + 50% vandaag verwacht ik
    Yep, ik ook! Gok op opening tussen de $ 5,50 en $ 6,00. Heerlijk kerstfeest voor de boeg!! Kassaaaaaaaaaaaaaaaaaaaaa!!!! Gefeliciteerd! Ik verkoop trouwens gelijk bij opening. Maar pak ze zeker weer op als de koers weer tot rust gaat komen. Ik verwacht namelijk veel winstnemers bij opening beurs! Succes!
  5. [verwijderd] 23 december 2009 19:22
    Goedenavond heren, alles vandaag verkocht bij opening beurs. Winst is winst! Allemaal gefeliciteerd, was een mooie en zeer winstgevende rit. Ben daarna nog voller in DDSS gegaan en een positie gestart in CRIS.

    CRIS is een aandeel met zeer veel potentieel en zeker de moeite waard om je in te verdiepen.

    Welke aandelen hebben jullie nog meer?

    Grt en succes!
  6. [verwijderd] 28 april 2010 18:39
    April 28, 2010 12:00 PM Eastern Daylight Time
    pSivida Receives $15 million payment from Alimera Sciences
    WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a leader in the development of ophthalmic sustained release drug delivery products, today said it had received full payment of a $15 million note, including an additional $225,000 in accrued interest, from Alimera Sciences, Inc., pSivida’s licensee developing Iluvien® for the treatment of diabetic macular edema (DME).

    “pSivida’s focus is the use of our unique technologies to develop therapies for serious unmet medical needs. We target diseases that affect large numbers of people and that represent big commercial opportunities. We believe Iluvien for DME is an example of this”
    Dr. Paul Ashton, CEO of pSivida Corp. said, “We congratulate Alimera on its successful IPO and look forward to Alimera’s filing of the NDA for Iluvien for the treatment of DME.” Alimera has stated that it intends to file the NDA for Iluvien this quarter and to seek priority review, which, if granted, is expected to result in a response from the FDA in the 2010 fourth quarter. If the FDA approves Iluvien for the treatment of DME, pSivida is due to receive a $25 million milestone payment from Alimera. pSivida would also be entitled to receive 20% of the net profits of sales of Iluvien.

    “pSivida’s focus is the use of our unique technologies to develop therapies for serious unmet medical needs. We target diseases that affect large numbers of people and that represent big commercial opportunities. We believe Iluvien for DME is an example of this,” Dr. Ashton said. He added that pSivida is developing other ophthalmic products, some in partnership with Pfizer, pSivida’s largest shareholder, and some internally. pSivida is also working to adapt its drug delivery platforms to deliver therapeutics outside ophthalmology.

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