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Below are brief summary updates to the site's database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results:
On Friday 05/06/09, Nephros (OTC: NEPH | Quote | Chart | News | PowerRating) shares rose 34.43% and have surged by over five-fold in just two weeks from 14 cents to 82 cents. This in the time from our initial article on extreme FDA trades on pending medical device decisions. NEPH.OB still has three separate FDA 510(k) applications pending at the agency, which are outlined below. Full details in today's report.
Bovie Medical (AMEX: BVX), on Friday, 05/06/09, company shares rose +0.11 (1.60%) as it currently has two pending medical device applications at the FDA, and the Company is working toward two additional 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology. While the two pending medical device applications outlined in our report do not have firm decision dates, our estimate for a possible FDA decision is currently some time during 3Q-4Q09 based on the review cycle for the Company's previous medical device filings.
On Firday 05/06/09, Nanosphere (NASDAQ: NSPH | Quote | Chart | News | PowerRating) shares closed at $5.10, rising +0.07 (1.39%) as the company has three 510(k) applications pending at the FDA with estimated decisions during 2H09, including diagnostic assays for cystic fibrosis and hemochromatosis (a disorder in which excessive amounts of iron are absorbed and accumulate in the body in tissues and organs such as the heart and liver), along with a second generation version of its Verigene System that incorporates automated sample processing.
A full, detailed report on the developments and how they affect other FDA decisions and approvals is available at BioMedReports.com:
http://biomedreports.com/articles/most-popular/1174-seven-extreme-fda-medical-device-trades.html
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/component/content/article/548.html
Disclosure: No positions.
About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
For more biomedical sector and investment news, go to www.BioMedReports.com
Certain sections of this report contain forward-looking statements that are based on our reporters' expectations, estimates, projections and assumptions. Words such as "expects," "anticipates," "plans," "believes," "scheduled," "estimates" and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, FDA announcements, trial and drug approvals, and company stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors including but not limited to the status or outcome of legal and/or regulatory proceedings.
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