Rated Bullish: Delcath Systems (NASDAQ: DCTH) and Neoprobe Corp. (AMEX: NEOP) |
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By Patrick Crutcher | |
Thursday, 17 February 2011 11:47 | |
We’ve been fans of Delcath since the $5.80’s back in the fall of 2010. Recently their shares have begun to surge, likely in anticipation of whether or not the FDA will accept their NDA. Delcath is expecting to hear back from the FDA on or around February 22nd; they’re hoping to receive a 6 month priority review. Delcath expects to hear back from the EU on their CE Mark sometime this year. Besides this, there are some other near-term events that will be important for this company. As we told our premium subscribers a few days ago, something that is potentially related to the Phase 2 results was recently uncovered in the brochure for an upcoming oncology meeting. On Sunday, February 20th at 5:00 pm, Dr. James Pingpank will be giving a presentation entitled "Update on Liver Perfusion" at the Sixth International Symposium on Regional Cancer Therapies. Dr. Pingpank has been an active clinical investigator with Delcath in the past; most recently he delivered their pivotal Phase 3 results at ASCO 2010. He also serves on their Medical Advisory Board and is a Senior Investigator at National Cancer Instute, the organization conducting their Phase 2 study in primary liver cancer. Their Phase 2 study recently completed in the fall of 2010, so it wouldn’t be too surprising for these results to be the topic of his discussion. These results are very important to Delcath’s valuation, since the market for primary liver cancer is vastly greater than the market for their current NDA. We’d expect to see some volatility in shares of Delcath over the next week or so, especially with the news on the FDA’s response and possibly clinical results.Now, let’s turn our attention to Neoprobe. They recently announced that their Phase 3 study of Lymphoseek in breast cancer and melanoma had recently met it’s accrual objective. We’d expect to see results sometime later this month or in early March. Again, we fully expect that NEO3-09 will yield positive results similar to their NEO3-05 study. David Bupp, Neoprobe’s President and CEO had this to say: “We are highly confident that the end points of the clinical study will be met and anticipate that full data will be available early in the second quarter following review by our clinical team. We will hold a conference call at that time to discuss the clinical study results and the presentation of the results are planned at scientific conferences later in the second quarter.” Neoprobe’s Phase 3 Lymphoseek Study Reaches Accrual Goal - http://bit.ly/euhNQz
Disclosure: Long DCTH and NEOP ![]() "Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |