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

To: Arthur Radley who wrote (206)	10/4/2009 7:10:14 PM
From: John McCarthy	Respond to of 421

Hi Arthur Thank you for posting that .... and I will post entire results on this thread Part One - At the risk of you muttering "he's nuts" ... I have already come to the conclusion that if the ILuvien P3 did "just as well" as the PK trial then the FDA will approve the LOW DOSE ..... Stated differently - the low dose MISSES its end point and nonetheless gets approved and is successful in the market place My real P3 concerns are: --- That the P3 low dose does AS WELL as the PK trial. --- That IOP is 0% in P3 Stock Price (I have not sold) I read somewhere that "technically" PSDV could pull back to $1.47. (mumbo jumbo reason) . If it gets at or below $2.50 gonna ask the dealer for 10,000 more chips. Part Two - Lucentis Either - $2,600 month or $2,000 month or $31,500 a year or $24,000 a year PLUS monthly injections ..... BRAVO (FVF4165g) -- 55% (0.3 mg) > 15 letters -- 61% (0.5 mg) > 15 letters CRUISE (FVF4166g) -- 46% (0.3 mg) > 15 letters -- 48% (0.5 mg) > 15 letters both results look SUPER to me ..... SIDE EFFECTS An analysis of the six-month data from both studies showed a safety profile consistent with previous Lucentis Phase III trials in wet (neovascular) age-related macular degeneration (AMD). Common ocular adverse events in both studies that occurred more frequently in the Lucentis arms than in the control group included conjunctival hemorrhage, retinal exudates, and eye pain. Serious ocular adverse events were uncommon and in the BRAVO study included one case of retinal detachment/tear in the 0.3 mg dose group and one case of endophthalmitis in the 0.5 mg dose group. In the CRUISE study serious ocular adverse events were uncommon with one case of vitreous hemorrhage in the sham injection group. No cases of endophthalmitis were reported in any of the treatment arms during the six-month treatment period in CRUISE. Among non-ocular serious adverse events in the BRAVO study, one cerebrovascular accident occurred in the sham injection group and two events occurred in the 0.5 mg dose group: one cerebrovascular accident that resulted in death and one myocardial infarction. In CRUISE, non-ocular serious adverse events were uncommon and included one case of either myocardial infarction or acute coronary syndrome in each of the three groups. No cerebrovascular accidents or deaths occurred during the six-month treatment period in CRUISE. About RVO RVO occurs when blood flow through a retinal vein becomes blocked, causing swelling (macular edema) and hemorrhages in the retina, which may result in vision loss. Sudden blurring or vision loss in all or part of one eye is common with RVO. RVO can affect people across a wide range of ages, from young, working-aged adults to the elderly. There are two main types of RVO: branch-RVO, which affects an estimated 868,000 people, and central-RVO, which affects an estimated 259,000 people in the United States.1 Branch-RVO occurs when one of the branches of the main vein of the eye becomes blocked. Central-RVO occurs when the main vein of the eye, located at the optic nerve, becomes blocked. My thoughts -- Lucentis It works and its DEAD - once the Avastin trials are in. If Avastin - for some reason BURPS - then it would just help Iluvien. The Lucentis/Avastin problem. To keep the numbers easy lets say Avastin costs $100 a month (avg is closer to $60) = $1,200 year. So thats equals Lucentis @ $24,000 a year vs Avastin at $1,200 a year. This means Genentech is going to take a 95% hit [DROP] to their top line for DME and Wet AMD Don't know how but --- Genentech will GO SLOW on Avastin trial results. And - if it does well - Avastin price has to change but thats a hard thing to do given eye docs are buying the cancer package and reconforming to multiple small doses for the eye. In closing - I know the FDA is IFFY - but they ain't stupid 1 shot = a 12 month fix .... (and perhaps a 15 month fix) ...... and no IOP bad dreams ... nobody (not even the FDA ) is nuts enough to throw that ACCOMPLISHMENT in the toilet ... regards John