The following is a comparison of Apricus Bio, whom is awaiting FDA approval for Special Protocol Assessment on ProvOnco (liver cancer) during 1st quarter 2011 and Threshold Pharma, whom received this designation for TH-302 (soft tissue sarcoma) in the pre-market of Wednesday’s trading session.
Few and far between from the investment community had been aware of Threshold Pharmaceuticals, a small company based out of California whose shares rose 80% at one point, before cooling off to 57.14% higher on nearly 16 times average volume. The interest was sparked by their product, TH-302, a novel treatment for soft tissue sarcoma, which received a Special Protocol Assessment (SPA designation by the FDA for their phase 3 randomized trial designation by the FDA. “With this SPA, we have reached agreement with the FDA on the key features of our Phase 3 trial design that will be necessary to support the registration of TH-302,” said Stewart Kroll, Threshold’s Vice President, Bio-statistics and Clinical Operations.
So just what makes an SPA designation so important you may ask? This particular declaration from the Food and Drug Administration allows for an uncompleted Phase 3 trial’s design, clinical endpoints, and statistical analyses to be acceptable for FDA approval. This then implies that it helps in expediting the process of approval, allowing for faster marketability and thus the opportunity to grab hold of the market prior to any competitors.
No comments:
Post a Comment