Another approach is to use an interim analysis of the surrogate endpoint data as the basis for accelerated approval, with continuation of the randomized trials during the time period when the surrogate endpoint and interim safety data are being: (1) analyzed, (2) prepared for submission to FDA, and (3) reviewed by FDA. When the ultimate clinical outcome can be expected over this additional timeframe, the data to verify the clinical benefit may be nearly complete by the time of accelerated approval. " Guidelines
Material Events | NWBO Message Board Posts
45 mins ago - (or perhaps you're suggesting the DSMB made the rec to halt, the Sponsor approached the FDA who advised continue, and they took the FDA's
Sr. Columnist at TheStreet, aka the Col. Jessep of biotech/drug stocks. Data Are. I curse. Said one analyst: The likes of Adam Feuerstein attack viciously
4 hours ago - BETHESDA, Md., June 16, 2014 /PRNewswire/ -- Northwest ... a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers. ... with extraordinary upside potential that are flying under Wall Street's radar.
Written by Vaccine Nation (Cameron Bisset in Press Releases
First Case Study Announced While Broader Data Being Collected;
Evidence Indicates Substantial Tumor Necrosis and Initial Tumor Regression -
Selection for inclusion in these indexes is based upon market capitalization and other market factors relating to a company and its stock. Membership in these indexes is updated annually, and remains in place for one year.
Shares Sold Short
Short Positions (05/30/2014)
6.68 Million Shares
Change from Last
Percent of Float
Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $5.2 trillion in assets currently are benchmarked to Russell Indexes.
"We are very gratified to be added to both the Russell Global and the Russell 3000 Indexes," commented Linda Powers, CEO of NW Bio. "It is an important reflection of NW Bio's strong progress and accelerating momentum on multiple fronts (both on the science and clinical fronts and on the business and finance fronts). Inclusion in these indexes will also increase awareness of NW Bio's strong performance among institutional fund managers both in the US and abroad."
If that breakout triggers soon, then NWBO will set up re-test or possibly take out its next major overhead resistance levels at $8 to $9 a share. Any high-volume move above those levels will then give NWBO a chance to re-test its 52-week high at $10.64 a share.
Sales Growth is very high though Margin dropped - If Mkt sold 30 million shares but somebody bought it too....