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To: John McCarthy who wrote (1139)	9/17/2010 5:18:02 PM
From: John McCarthy	Read Replies (1) \| Respond to of 1182

RVX.TO Archie, you don't seem to be intentional uniformed but I not sure if your just a paid basher or geniunely have concerns Lets get you up to speed with this comment from BFW on another board If the just-released statin metadata study turns out to be accurate and if RVX's NexVas program turns out to deal with far more fundamental causes of CVD (reverse cholesetrol transport [RCT] and inflammation) then the NexVas program could produce drugs that supplant almost all current CVD treatments. We could be looking at sales of $30 billion per year and more. We may even be looking at near universally prescribed preventive treatment with this. Absolute monster in the waiting..." The metadata study showed no benefit for statins in primary prevention with regards to mortality. I'm sure the stats were done correctly so it has internal accuracy. I suspect it is valid as well as Nissen said ""Because mortality is low in primary-prevention patients, it is difficult to show a mortality benefit. This has been established previously. The primary benefit in this setting is reduction in nonfatal MI, which remains a worthwhile goal of therapy," So..the Jupiter study still stands out as for primary prevention... but they selected patient with high hsCRP levels so it was primary prevention in an "inflamed" group. The metadata study above took all comers. One would expect that RVX208's niche would be in focusing on either an inflamed group or a group with low HDL/low ApoA1. One might even postulate that they would have an easier time showing a benefit for RVX208 in a group of patients exhibiting both of the above characteristics. If I was designing the trials, I'd want to focus on those most likely to show a statistically significant benefit in the shortest period of time. Hopefully, RVX is using the ASSERT data in this manner to tweak the ASSURE trial. Furthermore, even if RVX208 only shows a benefit in a specific group prior to coming to market, one would suspect that the use of the medication would leak out in to primary prevention. messages.finance.yahoo.com CRACKER

To: John McCarthy who wrote (1139)	9/17/2010 5:24:33 PM
From: John McCarthy	Respond to of 1182

PSDV Alimera Files for EMEA Approval in Diabetic Macular Edema Following a recent NDA application for the diabetic macular edema (DME) drug Iluvien, Alimera Sciences (ALIM) also submitted a Marketing Authorization Application (MAA) to the EMEA for the same drug. The filing for Iluvien, which was licensed to Alimera from pSivida Corp. (PSDV), includes data from the 24-month low dose phase III study known as FAME. The FAME study is ongoing and will be completed later this year. DME involves swelling of the retina due to fluid leaking from blood vessels in the eye. For diabetics, there is only about a 10% lifetime risk of developing the disease, but treatment for the disease involves monthly eye injections that are either costly (Lucentis), unproven (Avastin), or generally avoided (corticosteroids). Iluvien, in comparison, is an injection that has a sustained-release drug delivery system of fluocinolone that can last for years with data on its three-year efficacy coming later this year. Iluvien took the correct path in entering the ever-growing, multi-billion dollar DME market. With the efficacy of Roche’s Avastin and Lucentis already being quite tough to improve upon and with Avastin poaching sales from Lucentis due its significantly decreased price, creating a product that will last for years as opposed to months is a by far the best method of entry. Using this approval as a springboard, Alimera can begin to move into other ophthalmic markets currently owned by Roche and develop Iluvien into a multi-billion dollar drug. biosmash.com CRACKER