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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (2509)	6/12/2009 9:02:09 AM
From: Jibacoa	Read Replies (2) \| Respond to of 3722

SVNT is up 45.03% in pre-maket trading.<g> The stock is trading at $8.65 above its January H. :>) bigcharts.marketwatch.com It announced on 5/7/09 that its pending BLA for Krystexxa for treatment of gout patients, will be reviewed by an Arthritis Advisory Committee of the FDA on 6/16/09. Back in December, the FDA accepted the BLA and granted priority review status. However,after SVNT submitted several key amendments for the BLA in January,the FDA determined that the additional information constituted a major amendment and had extended the original action date to 8/1/09. Bernard

To: Jibacoa who wrote (2509)	5/12/2010 11:53:40 AM
From: Jibacoa	Respond to of 3722

VICL also opened with a small UG but it is still trading below its Apr29 H of $3.86. It needs to close above that before it can test the March 10 H at $4.12 <g> bigcharts.marketwatch.com VICL was able to trim some its loss on the 1stQ in spite of 36% lower revenues.The L for 2010 is expected around $0.52 vs. $0.61 last Yr. and for 2011 the expected loss is still around $0.50 <g> VICL announced the publication in the June issue of Melanoma Research of updated data from its PII of high-dose (2 mg) Allovectin-7(R) in patients with metastatic melanoma. In the PII 127 chemo-refractory or chemo-intolerant patients were treated with high-dose Allovectin-7(R). There were no treatment-related Grade 3 or Grade 4 adverse events, and no withdrawals from the trial for tolerability. The overall response rate was 11.8%, with 4 complete responders and 11 partial responders. The median duration of response was 13.8 months, ranging from a minimum of 6 months to a maximum of 66 months and still ongoing.<g> Median survival was 18.8 months. The data compare favorably vs. historical controls from other studies in metastatic melanoma. The PIII,which was initiated in Jan2007, is evaluating Allovectin-7(R) as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. VICL completed enrollment in Feb2010 of approximately 390 chemo-naive patients randomized on a 2:1 basis: approximately 260 for treatment with Allovectin-7(R) and approximately 130 for treatment with either dacarbazine or temozolomide. It expects to complete patient follow-up and lock the PIII database in mid-2011. Allovectin-7(R) has the potential to be the first new primary treatment approved for metastatic melanoma in nearly 20 years. Vical estimates that the worldwide market for Allovectin-7(R) as a treatment for metastatic melanoma could exceed $500 million annually, and applications for other types of cancer could further expand its total use. Because the mechanism of action for Allovectin-7(R) is not melanoma-specific, it has the potential to be used in other types of solid tumors. I remember more than 12 years ago, when somebody on an article on Barrons' "Round Table" was predicting that VICL was going to trade sbove $100 that Yr., when the stock was trading around $3 Of course those wild predictions were not uncommon at that time.<g> The expectations at that time was about VICL's vaccines, and although the stock didn't make it to the $100 level, it had a nice run in late 1999 and early 2000, of which I still have some fond memories.<g> bigcharts.marketwatch.com Bernard