We originally bought ACAD around $6.00 per share here ACAD Pharmaceuticals - ACAD. ACAD is up pre-market 50% to around $12.00 on news that it will seek FDA approval for Pimavanserin a Parkinsons disease psychosis drug. After meeting with the Food and Drug Administration and based on data from a successful phase III study already completed the company will no longer conduct a confirmatory phase III study that was planned to start this month. The company is currently targeting NDA submission (new drug application) by the end of 2014.
Bottom Line: The phase III study that was released last November was statistically significant. Having the opportunity to skip a second phase III study will eliminate approximately a year or more from potential approval to drug to market. The company is a strong candidate for acquisition by large pharma as the patent coverage for Pimavanserin is 2028. Thank you for reading.
Bottom Line: The phase III study that was released last November was statistically significant. Having the opportunity to skip a second phase III study will eliminate approximately a year or more from potential approval to drug to market. The company is a strong candidate for acquisition by large pharma as the patent coverage for Pimavanserin is 2028. Thank you for reading.
No comments:
Post a Comment