The Acadia 2nd quarter conference call went extremely well. The company still targets the end of the year to file the NDA for PDP. What's even more important is they plan to file an application in the EU for Parkinson's Disease Psychosis six to nine months after filing the NDA with the FDA here in the U.S. The EU filing has been an overhang on the stock for some time now. If the company had to run another Phase 3 trial in the EU for PDP, it could take up to another three years and a huge cash drain for that trial.
Future Trials:
Sleep disturbance trial (2014-2015) for Parkinson's patients. Trial is currently being designed.
Schizophrenia (2015) as Mono-therapy for maintenance stage and symptom control. Patients cannot tolerate staying on the current approved drugs for an extended period of time.
Safety Stats:
250 patients have been on Pima for one year or longer, 100 patients at least two years or longer, with the longest single patient exposure exceeding eight years.
Bottom Line: The new information learned today from the company, was related to the potential filing of a marketing authorization application (MAA) in the EU 6-9 months after filing the new drug application with the FDA. In other words, they are using the NDA as a fore runner for filing the MAA in the EU. The company is in a very strategic position with patent expiration until 2028, and the company holds worldwide rights to Pimavanserin. Thank you for reading.
Future Trials:
Sleep disturbance trial (2014-2015) for Parkinson's patients. Trial is currently being designed.
Schizophrenia (2015) as Mono-therapy for maintenance stage and symptom control. Patients cannot tolerate staying on the current approved drugs for an extended period of time.
Safety Stats:
250 patients have been on Pima for one year or longer, 100 patients at least two years or longer, with the longest single patient exposure exceeding eight years.
Bottom Line: The new information learned today from the company, was related to the potential filing of a marketing authorization application (MAA) in the EU 6-9 months after filing the new drug application with the FDA. In other words, they are using the NDA as a fore runner for filing the MAA in the EU. The company is in a very strategic position with patent expiration until 2028, and the company holds worldwide rights to Pimavanserin. Thank you for reading.
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