Oct. 5, 2009 (Baystreet.ca) --
Oncolytics Biotech, Inc. (NASDAQ:ONCY) makes our list of stocks to watch after reaching an agreement with the U.S. Food and Drug Administration under the special protocol assessment process for the design of a Phase 3 trial examining REOLYSIN in head and neck cancers.
On Friday, Oncolytics said it's the first company to reach an agreement with the FDA on a Phase 3 trial design for an IV-administered oncolytic virus under the SPA process. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data. The stock traded above it's 52-week high on Friday, but shares ticked down a bit after hours. As news spreads about this key development, interest in the company may rise as well since a license application submission for REOLYSIN would become a major development for the Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.
Insiders at Cel-Sci Corporation (NYSE AMEX:CVM) had been buying shares at open market prices just days before a vastly under researched story hit the news wires on Friday. Rumors about the latest report filings with the SEC had begun to spread and had prices for shares significantly rising above market close last Thursday after hours, but enthusiasm for the stock was dampened when the hit piece from the Street.Com took aim at them.
If you watch patterns, you've seen the same type of "bullish" insider buying activity take place on countless other occasions, but perhaps the most recent example comes from Human Genome Sciences (NASDAQ:HGSI) just days before news about BENLYSTA made shares jump significantly.
Specific details about a number of upcoming catalysts have yet to be disclosed by the company, but readers of this space know that the Cel-Sci has several pending news items due, including the unveiling of their new state-of-the-art cold fill laboratory, any number of announcements regarding their newly (FDA) fast-tracked H1N1 flu treatment human studies as well as official news about the launch of Phase III studies for Multikine.
Multikine is the company's multi-targeted, cancer immunotherapy which performed well in Phase II, but had been sidelined while said laboratory was being built to accommodate the production of the sensitive and complex biologic drug candidate platform.
Those looking for "tells," certainly point to news about the new laboratory as one such positive indicator.
