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kei

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Alias Born 10/10/2007

kei

Re: $heff post# 96822

Friday, 05/05/2017 9:59:36 PM

Friday, May 05, 2017 9:59:36 PM

Post# of 97239
$PSDV.. Ph3 data due by June 30th + abstract of Treatment of Posterior Segment Uveitis will be out Monday 8:00AM--8:15AM (link) http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=1017444

Durasert™ Three-Year for Posterior Segment Uveitis:
* Report top line results from the second pivotal Phase 3 clinical trial in June 2017.
* Submit the European Market Authorization Application (MAA) in June 2017.
* File an NDA in the U.S. during the fourth quarter of calendar 2017.
* Pre-clinical safety and PK studies of its next generation shorter acting Durasert for posterior segment uveitis remain on track to commence in the second quarter of calendar 2017.
* Present clinical study data at leading medical conferences, including the Association for Research in Vision and Ophthalmology (ARVO) annual meeting on May 8, 2017 and American Society of Retina Specialists (ASRS) annual meeting in August 2017.

Other Durasert Related Developments:
* Full enrollment for the Phase I knee osteoarthritis (OA) investigator-sponsored clinical trial was achieved with Hospital for Special Surgery (HSS). The Company expects HSS to report the Initial 24-week data by the fourth quarter of calendar 2017.
* The Company entered into a funded feasibility study agreement with a leading biopharmaceutical company in March 2017. The Company expects to consummate one or more additional collaboration agreements in calendar 2017.


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