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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (3322)	4/3/2001 2:17:53 PM
From: Biomaven	Read Replies (2) \| Respond to of 52153

It sure is hard to know when this slow-motion crash is going to end. We still have about a week or so of potential selling pressure for tax payments, and I'd suggest caution until that is out of the way. But watch out for fire-sales like yesterday's NOVN. Personally, over the last week or so I've upped my short in QQQ, but bought a little MSFT (its biggest component) because I think the next OS upgrade cycle is for real. (Win98 2nd edition and WIN ME certainly weren't.) Also added to my BBH short some. Right now my positions are about 65% long (virtually all biotechs), 35% cash or treasuries and about 10% short a combination of the QQQ and BBH. Nice looking result on daptomycin by CBST today, but the market doesn't seem to care. :( Peter

To: Jibacoa who wrote (3322)	4/4/2001 12:07:03 AM
From: Scott H. Davis	Respond to of 52153

RE: VICL being on the + side today - looks like there was some buying by some that had a "heads up" This came out after close Vical Projects Completion of Allovectin-7(R) Registration Program SAN DIEGO, April 3 /PRNewswire/ -- Vical Incorporated (Nasdaq: VICL - news) announced today that the U.S. Food and Drug Administration (FDA) has reconfirmed that the company's Phase II and III trial designs could support registration of Allovectin-7® for melanoma, and that the company expects to complete enrollment of patients in its Phase III trial in the third quarter of 2001. Written comments received from the FDA, following a face-to-face status review meeting, reconfirmed the acceptability of the company's registration program to support marketing approval if the data meet the study objectives. A robust clinical outcome in one of the Phase III trial's two endpoints, with no detriment in the other, would be sufficient to warrant consideration for marketing approval, if the company also meets product manufacturing and other typical regulatory requirements. In addition, the FDA reconfirmed that the Phase II registration trial could, on its own, be the basis for marketing approval, if the data meet the clinical endpoints. Enrollment of patients in the Phase II trial was completed in January 2001, and interim results will be presented in May at the annual meeting of the American Society of Clinical Oncology. The FDA further confirmed that data from the Phase II trial and prior trials with Allovectin-7® would support a submission based on Phase III trial results, assuming that the Phase III data profile is consistent with prior experience. Vijay B. Samant, Vical's President and Chief Executive Officer, said, ``We are pleased that the FDA has reaffirmed that our current trials could form the basis for approval of Allovectin-7®, and excited that enrollment in our registration program is approaching completion. Everyone involved in this program has worked long and hard to reach this point. ``We are excited that Allovectin-7® has the potential to be the first gene-based product to gain marketing approval,'' added Mr. Samant, ``and we would consider successful commercialization as further validation of naked DNA gene delivery. Preparation for the commercial launch of Allovectin-7® continues to be the focus of Vical's activities.'' Registration Program Vical's Allovectin-7® registration program consists of two separate trials in patients with metastatic melanoma, either or both of which could lead to registration for their respective patient populations if endpoints are achieved. The Phase II trial is designed to confirm the efficacy of Allovectin-7® in patients with refractory (unresponsive to standard therapy) melanoma that has not yet spread to multiple internal organs. The Phase III trial is designed to demonstrate the efficacy of Allovectin-7® when used with standard chemotherapy in patients with metastatic melanoma not previously treated with chemotherapy. Vical Incorporated, The Naked DNA Company(TM), is focused on the development of pharmaceutical product candidates based on its patented gene delivery technology. A number of therapeutic and vaccine product candidates are currently under development for the prevention or treatment of cancer, infectious diseases and metabolic disorders by Vical and its collaborative partners, including Merck & Co., Pfizer Inc., Aventis Pasteur, Aventis Pharma, Human Genome Sciences, Centocor Inc., Merial and Boston Scientific Corporation. Allovectin-7®, which uses a lipid-DNA complex to help the immune system recognize and attack cancer cells, is in Phase II and Phase III testing in certain patients with metastatic melanoma and in Phase II testing in patients with head and neck cancer. Leuvectin(TM), which uses a lipid-DNA complex to stimulate an immune response against cancer cells, is in Phase II testing in patients with kidney cancer and prostate cancer. Vaxid, a naked DNA vaccine to prevent relapse of B-cell lymphoma, is in Phase I/II testing. In collaboration with the National Cancer Institute, a naked DNA vaccine to treat metastatic melanoma is in Phase I/II testing. If you are interested in any of Vical's clinical trials, please see our website at www.vical.com, or contact Tammy Boyce by phone at 858/646-1120 or by e-mail at tboyce@vical.com.