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Biotech / Medical : PSDV - pSivida Limited -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (94)	9/9/2009 7:48:06 AM
From: John McCarthy	Respond to of 421

Press Release .... pSivida to Webcast Presentation at Rodman & Renshaw Health Care Conference Press Release Source: pSivida Corp. On Wednesday September 9, 2009, 7:30 am EDT Companies:PSivida Corp. BOSTON--(BUSINESS WIRE)--pSivida Corp, (NASDAQ:PSDV - News)(ASX:PSD - News)(FF:PSI), a leading drug delivery company, today announced it will webcast a live presentation at the Rodman & Renshaw Annual Health Care Conference in New York, September 10. Dr. Paul Ashton, president and chief executive officer, will present at 12:30 p.m. Eastern time. A live audio webcast of the presentation will be available at wsw.com and at the company’s website: www.psivida.com. A replay of the presentation will be available at the company’s website for 90 days. About pSivida Corp. pSivida is a world leader in the development of miniaturized, injectable, drug delivery systems for the eye. pSivida’s lead development product, Iluvien™, delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME). Formerly known as Medidur™ FA for DME, Iluvien is in fully recruited Phase III clinical trials. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida also has two products approved by the Food and Drug Administration (FDA): Retisert® for the treatment of uveitis and Vitrasert® for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products. pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida has completed an initial safety clinical trial of BrachySil for the treatment of pancreatic cancer and is conducting a follow-on dose-ranging clinical trial. pSivida’s intellectual property portfolio consists of 45 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom. SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking and involve a number of risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the forward-looking statements: failure of FA or the Iluvien device to act as a VEGF inhibitor or neuroprotectant; inability to expand the treatment indications for Iluvien; maintaining key collaboration agreements with Alimera and Pfizer; modification of existing terms of key collaboration agreements with Alimera and Pfizer; uncertainties regarding the achievement of milestones and other contingent contractual payment events; failure to prove safety and efficacy of Iluvien or BrachySil; inability to raise capital; continued losses and lack of profitability; inability to derive revenue from Retisert; termination of license agreements; inability to pay any registration penalties; inability to develop or obtain regulatory approval for new products; inability to protect intellectual property or infringement of others’ intellectual property; inability to obtain partners to develop and market products; competition; risks and costs of international business operations; manufacturing problems; insufficient third-party reimbursement for products; failure to retain key personnel; product liability; failure to comply with laws; failure to achieve and maintain effective internal control over financial reporting; impairment of intangibles; volatility of stock price; possible dilution through exercise of outstanding warrants and stock options or future stock issuances; possible influence by Pfizer; and other factors that may be described in our filings with the Securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. We do not undertake to publicly update or revise our forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied in such statements will not be realized. finance.yahoo.com

To: Arthur Radley who wrote (94)	9/9/2009 11:15:27 AM
From: kenhott	Read Replies (2) \| Respond to of 421

I will bring the conversation over here where it belongs. You should know that I can't write so my post was about looking at the stock and not about buying into the stock. But if I did, I would always buy at the low and sell at the high. I looked at the stock yesterday. I did not look at all the links that John posted (Thanks... I think), all 3 zillion of them. So I am not claiming anything about thoroughness, etc. At current price, it is around a $65m market cap. The issue about this stock is not efficacy but safety as you pointed out. I think they will hit the efficacy button but not sure about the safety button. PSDV obviously knows the issues and so therefore the low dose arm of .23 microgram/day (.45 is the high dose arm). They are keying off of Retisert(?) which starts at a release rate of .6 microgram/day then goes down to .3-.4 after about a month (I think?). So the high/low arm approach basically brackets the Retisert dose. B&L tested Retisert in Diabetic Macular Edema (DME). They stopped the drug for DME (as far as I can tell) because of safety, Intraocular pressure (IOP) and cataracts. In one trial by year 3, 33% of the patients needed surgery for IOP and 95% of the patients needed cataract surgery. Retisert is approved for Chronic Noninfectious Posterior Uveitis, which is a different beast. The only other treatments I know of are all like Retisert, steriod based. I think some docs use like systemic methotrexate, etc. for 2nd line but these alternatives to Retisert all have their only serious issues. So there is a place for Retisert in CNPU. In DME, we have lasers and probably Lucentis and Avastin, etc. Competition brings the focus to safety. That's why Retisert is good for CNPU but not for DME. PSDV's drug, Medidur or IIuvien or whatever they are calling it this moment, lasts for 36 months in the eye. They are hoping that by lowering the dose and getting the implant far away from the lens, they can get away from the safety issues. The issue is long term safety not over 3 months or 6 months, etc. This device lasts 3 years. Removing the insert is not something that should be part of the regular treatment plan. They are giving updates from the ongoing PK trial that is running with the phase 3 trials, it has a small number of patients in what they are calling low/high arms. At 12 months, IOP for low dose looks great but no data for cataracts. We all know when they leave something out, it ain't a good sign. Looking back, at 3 months, low dose had 5% cataract rate and at 6 months, low dose had 10% cataract rate. Why are they hiding the cataract numbers at 12 month when they had PR'd it before? My guess is that Lucentis, etc. will be proven to work fine in this indication. We all know that Avastin is going to be cheap. The benefit of this device is one shot, 3 years. MAJOR benefit but must be balanced by the safety of the device. Let's assume low dose works, at some % of cataracts, they won't pass the FDA. And at some lower %, they will have trouble competing I am guessing. I wonder how widely docs are using Avastin for DME right now? The 18 month update is right around the corner. I am sure the company is hoping that the cataract numbers stay put but given the nature of the drug interaction, I would expect the number of events to go up over time all the way to 3 years. Valuation is the key over time. Short term, the 18 month data rules. I am not claiming to be an expert or that I have been thorough or that I am right. Just a quick shot at the goal of understanding what is going on. Good luck.