pSivida Limited (ADR) (NASDAQ:PSDV)

pchop123 (76.55) Submitted: 5/21/2013 11:54:32 AM : Start Price: $2.95 PSDV Score: -5.54

smart short

zzlangerhans (99.79) Submitted: 4/6/2013 7:11:17 PM : Start Price: $2.22 PSDV Score: -31.46

pSivida has surged again on word that Alimera has submitted their response to the Iluvien CRL to the FDA.

However, the CEO's recent description of their plan for approval of the FAc insert for posterior uveitis is a masterpiece of doublespeak.

"our posterior uveitis product uses the same micro-insert as ILUVIEN®, which has received marketing authorizations in various EU countries for chronic diabetic macular edema "

"The U.S. Food and Drug Administration’s (FDA) decision to allow us to reference much of the ILUVIEN data for DME, including the clinical safety data, from Alimera Sciences’ already-completed pivotal Phase III clinical trials, has the potential to both simplify any future NDA submission and to shorten development time."

Both statements are absolutely true. Iluvien was approved in the EU and the posterior uveitis therapeutic uses the same FAc insert as Iluvien. What's the missing piece of information? The FDA delivered a shocking and emphatic rejection of Iluvien based entirely on safety concerns related to the FAc insert. Therefore, the fact that the posterior uveitis therapeutic uses the exact same FAc insert is a huge negative, not a positive. pSivida is simply hoping that the FDA will come up with a different risk/benefit calculus this time around. Do you want to take that bet along with them?

diggerdan28 (49.60) Submitted: 3/30/2012 7:20:23 PM : Start Price: $1.84 PSDV Score: +50.88

This stock is set for a BIG comeback, especially after June.

linkhbwill (< 20) Submitted: 11/30/2011 11:31:04 AM : Start Price: $1.40 PSDV Score: +86.70

I'm not sure onn this one, I think it will be o.k., but im just going to wait awhile but im pretty sure it will work out.

technicalalerts (< 20) Submitted: 9/13/2011 1:05:05 AM : Start Price: $4.31 PSDV Score: -69.89

watchlist

jacketfan61 (< 20) Submitted: 10/18/2010 3:10:46 PM : Start Price: $6.01 PSDV Score: -88.35

I've been in this stock since it was under $1. Have watched it carefully and knew with the backing of Pfizer, this medication would take this company to new heights. Wouldn't be surprised to see Pfizer absorb the company.

d0319a (< 20) Submitted: 9/22/2009 9:20:31 AM : Start Price: $5.99 PSDV Score: -103.09

phase three final in december

Ernbo6 (59.24) Submitted: 5/15/2007 8:35:36 AM : Start Price: $7.64 PSDV Score: +80.61

Sivida Limited is engaged in the development and commercialization of drug delivery products in the healthcare sector, initially in ophthalmology and oncology. The principal activities of the Company and its subsidiaries during the fiscal year ended June 30, 2006, included patent maintenance and lodgement of new patents with regard to its drug delivery platform technologies; collaboration and commercialization of applications to its platform technologies; promotion of the Company both domestically and internationally, and further investigation of future collaboration partners and product applications. In December 2005, pSivida Limited acquired Control Delivery Systems Inc (CDS). CDS designs and develops drug delivery products. On completion of the acquisition, CDS was renamed pSivida Inc.